GMP Audit Cosmetics Products - proqc.com · The factory has been certified to ISO 22716: 2009 for cosmetic products by SGS since 17th Sep, 2016 ... implement Good Manufacturing Practices?

GMP Audit Cosmetics Products

* Example Report *

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NAME : NAME :

ADRESS : ADRESS :

CITY : CITY :COUNTRY : COUNTRY :

PHONE : PHONE :FAX : FAX :

Mr./Mrs. Title: Email:Mr./Mrs. Title: Email:Mr./Mrs. Title: Email:Mr./Mrs. Title: Email:Mr./Mrs. Title: Email:Mr./Mrs. Title: Email:

Mr./Mrs. Title:Mr./Mrs. Title:

Complies Needs Improvement Does Not Comply

100.0% 0.0% 0.0%100.0% 0.0% 0.0%100.0% 0.0% 0.0%100.0% 0.0% 0.0%#DIV/0! #DIV/0! #DIV/0!100.0% 0.0% 0.0%100.0% 0.0% 0.0%100.0% 0.0% 0.0%100.0% 0.0% 0.0%100.0% 0.0% 0.0%100.00% 0.00% 0.00%100.00% 0.00% 0.00%100.00% 0.00% 0.00%75.00% 25.00% 0.00%100.00% 0.00% 0.00%100.00% 0.00% 0.00%100.00% 0.00% 0.00%100.00% 0.00% 0.00%88.89% 11.11% 0.00%100.00% 0.00% 0.00%75.00% 25.00% 0.00%100.00% 0.00% 0.00%

Training

CalibrationEquipmentPest ControlPremises

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GMP for Cosmetics Rev.SUMMARY

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PARTICIPATING PERSONNEL

Supplier Name Audit Date Report No.

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SUPPLIER INFORMATION CLIENT INFORMATION




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Maintenance

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CONTACT PERSONNEL

Non-conforming products

DocumentationChange Control

Bulk Product StoragePacking Operations

Subcontracting ManufacturingWaste Control

Personnel Hygiene and Health

Personnel

Identification and Status

Finished Products

AUDIT RESULTS

Quality Control Laboratory

Complaints and Recalls

Production

JUDGEMENT & RECOMMENDATIONS

Storage

Raw Materials and Packaging Materials

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Documentation Change Control

Complaints and Recalls Non-conforming products

Subcontracting Manufacturing Waste Control

Quality Control Laboratory Finished Products

Packing Operations Bulk Product Storage

Production Storage

Identification and Status Raw Materials and Packaging

Maintenance Calibration Equipment

Pest Control Premises

Personnel Hygiene and Health Training

Personnel

Complies Needs Improvement Does Not Comply

GMP, ISO 22716:2009 By: Pablo C. Approved by: Jean C. 6/7

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GMP for Cosmetics Rev

FACTORY PHOTO

37. Photo of production 38. Data analysis of defectives from production

36. Record of process card 37. Record of in-process inspection.

34. SOPs on site 35. Identification of semi-finish on site

1GMP for Cosmetics Rev.

SUMMARY

Supplier Name Audit Date Report No.

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SUPPLIER INFORMATION CLIENT INFORMATION


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provide a CAPA before engaging in any business with them.

your business. The better solution would be to source another supplier.

Passed, the QMS is effective, you could consider this supplier a reliable business partner.

Passed, the QMS is acceptable with minor NCFs (see Audit Report), you could consider this supplier a reliable business partner, but continue to require improvement to reduce risk.

On-hold, the QMS presents a few major NCFs (see Audit Report), you could request them to

Failed, the QMS presents major NCFs (see Audit Report) that could impact upon

0

Opportunities for Improvement:

2) The factory should define an adequate intensity of light for specific workshops or areas. The factory

lighting system3) An authory must review and approve the list of selected and approved suppliers.

must purchase a device that will the periodic conducting of inspections of the intensity of the

1) The factory must plan the type of evaluation to be conducted after training, and must keep a record.

3) Production manager with more than 12 years experience in the cosmetics industry.

Strengths:

2) Well maintained cleanroom of 100,000 class level.

4) Large show room, and enough space in the production area to enlarge production capacity.

1) Certified to ISO 22716: 2007, USA FDA and EU.

However, the factory must improvement enhance employee skill / training with effective evaluation system, others details of opportunities of improvement are listed here below:

The company is located in XXXXX city which is considered the biggest small commodity center in the world. The factory covers an area of 30000 square meters and has around 200 employees working full time. The factory has 4 mains buildings, one for offices, a workshop of 4 floors for production under 100,000 class level air purification plant,and one building for dormotories.

Supplier Name Audit Date Report No.XXXXXXXXXX

Scope of Audit:The intent of conducting a Quality System audit based on ISO 22716:2007 requirements is to provide the client with information useful for making an initial assessment about business viability, and reducing their sourcing risks.

The factory has been certified to ISO 22716: 2009 for cosmetic products by SGS since 17th Sep, 2016 which will expire on Sep 4th 2018. The scope of the certification includes Manufacturing of cosmetic products. The certificate number is CN12/20287. Meanwhile, the factory also obtained a compliance certificate for regional requirements of US FDA (CN/21333), as well as an EU compliance certificate. Evidence of compliance with those standards are available on-site.

The main market covers US, Europe, Russia, Japan, South America, Africa, etc, where they have been selling around 1000 various professional products.

GMP for Cosmetics Rev.REPORT

The audited factory XXXXXXXXXXXXXXXXXXXX was founded in 1992, it specializes in the production of cosmetics products such as Cosmetic Pencils, Powder Series, Color Cosmetics, Cosmetic Kits, Newness ...etc.

Summary/Recommendation:

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3.4.1.2 C1) Photograph training plan. 2) Number of subjects 3) number of subjects done.

Is an appropriate training program developed?

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Is there any procedure for identification of training needs?

Yes, there is a training program for 2017 with 29 trainings topics to be conduct in 9 different days (See photo 3)

1) Write procedure (Doc, Rev) 2) Describe how training needs are identified.

1) Commitment letter signed by the top management.

Supplier Name

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Audit Date

Personnel

Yes, the Quality Manual MX/GMPC-QM-001 contains commitment letter signed in 2015-06-01 to comply to requirements of ISO9001:2008, ISO22716-2007.

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EVIDENCEQUESTIONNAIRES FINDINGS

Are their job responsibilities defined and communicated to related personnel?

Training

Are department Managers committed to implement Good Manufacturing Practices?

1) Commitment letter signed by each department Manager

Yes, the Quality Manual MX/GMPC-QM-001 contains commitment letter signed in 2015-06-01 to comply to requirements of ISO9001:2008, ISO22716-2007.

C = Complies with the requirements, I = Improvement Needed, NC = Does Not Comply, N/A = Not Applicable

Is there an organizational chart available? Is the Quality Department independent?

1) Yes, there is an organization chart Quality Manual MX/GMPC-QM-001, Rev A, Page 6/67. 2) The Quality Manager is Mr. Tong, and he reports to GM directly. 3) The Quality Depart has 10 peoples.

1) Photograph the org. chart 2) Name the Quality Manager 3) How many QC in Quality Dept.? 4) Does he report directly to GM?

Is top management committed to implement Good Manufacturing Practices?

Yes, there is a procedure for employee training documented in the Quality Manual MX/GMPC-QM-001, Rev A, Page 27/67. Chapter 4 describes how training needs are identified.

1) Review Job Description of Quality Department.

Yes, job description and responsibilities of each Department are documented in the file MX-2-XZ-001, published since 2015-6-01.

Is proper information available to employees to comply with responsibilities assigned?

1) Interview Quality Manager if he know his JD. 2) Check if the JD is posted.

Yes, the Quality Manager knows his responsibilities. Job Description is documented and posted on-site (See photo 10).


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Are training courses appropriate to the jobs and responsibilities of individuals?

1) Review and photograph training need submitted by department

Yes, record of the following training was reviewed: 1) Requirement of GMPC, BRC knowledge conducted in 2016-3-15, and recorded in the sheet. Q/MX306001 (See photo 4). 2) Requirement of EEC conducted in 2017-06-19, and recorded.

1) Photograph hygiene program. 2) Describe the hygiene frequency.

Yes, there is a hygiene programme established as followed: Water hygiene (MX-2-XZ-003. Employee hygiene (MX-2-XZ-004). Contamination control (MX-2-XZ-005). Wash hand (MX-2-XZ-007) Pest control (MX-2-XZ-010)

Personnel Hygiene and Health

Do newly recruited personnel receive appropriate training?

Yes, new employees are trained about cleanness, personnel hygiene and health. Training records are available (See photo 5)

Is the type of evaluation documented? Is knowledge evaluated during and/or after training?

1) Review and photograph record of evaluation.

There is a procedure for employee training. MX/GMPC-QM-001, Rev A, Chapter 2.7, page 27/67 requires training evaluation to be conducted. But the factory was unable to show any records of such evaluation

1) Note subject to newly hired. 2) Photograph training records

Is a hygiene programme established and adapted to the needs of the plant?

Is the program followed in every area required? Are records posted.

1) Photograph in production / warehouse..etc.?

Yes, the program is followed, and records are kept: 1) Record of employee hygiene (See photo 6). 2) Record of machine cleanness in sheet Q/MX307019, for example of machine Nb. MX.1013 (See photo 8). 3) Record of equipment (See photo 9)

Are personnel instructed to use hand washing facilities?

1) Photograph if any facilities for hand washing? 2) Photograph if there is any Work Instruction posted on-site about how to wash hands.

1) Facilities for hand washing are provided (See photo 11). 2) WIs that instruct employees to wash hands are documented in WI MX-2-XZ-007, and posted in the workplace (See photo 12).

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Are they closely supervised if they are taken into the production, control and storage areas?

Is there any notice to prohibit storage of food, drink or smoking materials, personal medication in the production / warehouse posted on-site?

1) Photograph if any in production. 2) Photograph in warehouse

Yes, notice to prohibit storage of food, drink or smoking materials is posted on-site (See photo 14)

1) Check record demonstrating the exclusion and job transfer

Are any persons affected by an apparent illness or with open lesions on exposed body parts excluded from direct contact with product untilthe condition is corrected or determined by medical personnel that the quality of cosmetic products will not be compromised?

Are visitors/untrained personnel given information in advance, particularly about personal hygiene and the prescribed protective clothing?

Yes, the Auditor was accompagned by the Production Manager1) Is the auditor closely supervised

1) The Work Instruction MX-2-XZ-0043, Rev A/01 defines a control plan. 2) Each employee working in the critical area must do a health check-up at least once each year, and records are available (See photo 15). 3) Employees can take leave when they fill ill, records of leave are maintained as evidence. For example at Production workshop, it was found that 15 employees has take leave from 2017-7-1 to 2017-7-16, 7 out of 15 declared the reason of their leave as illness (See photo 16)

Yes, information is provided to external people in advance, as required on page 3/3 of WI MX-2-XZ-004. And it is also posted on-site. The auditor was accompanied by the production Manager, and he was required to sign a commitment (See photo 17)

1) Photograph if any instruction posted at the entrance of the premise. 2) Is the auditor instructed?

Premises

Is there any notice to prohibit eating, drinking, chewing, smoking posted on-site?

1) Photograph if any in production. 2) Photograph in warehouse

Yes, notice to prohibit eating, drinking, chewing, smoking is posted on-site (See photo 14)

Does every person who enters production, control and storage areas wear appropriate clothing and protective garments to avoid contamination of cosmetic products?

1) Photograph if any photo on side showing how to dress. 2) Check and photograph how operators are dressed?

Yes, each person entering the respective workplace MUST wear appropriate clothes and garments to avoid contamination (See photo 13)

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4.0.7 CYes, sanitization is carried out as per procedure. Records are maintained

Is the ventilation sufficient for the intended production operations?

Yes, the ventilation system meets the requirements of 100000 class level, according to the inspection report. (See photo 20

Yes, factory the floor and area are kept in a safe, clean and hygienic condition (See photo 18) Only material used for the production of planned PO are keep on-site on that day. Records are maintained.

Lighthing intensity look sufficient at the moment. However, there is no device for measuring the intensity, no plan and no record.

Yes, separate areas are provided 1) Production area (See photo 18). 2) Warehouse (See photo 19) 3) Hand washing room (See photo 11), Toilets area, Dressing area…etc

1) Make a tour in the production building (Internal / external)

Are separate or defined areas provided for;a) Storage.b) Production.c) Quality control.d) Ancillary.e) Washing.f) Toilets.

Is cleaning and, if necessary, sanitization carried out to achieve the objective of protecting each product?

Yes, floors, walls, ceilings and windows in production areas are designed/constructed as per requirement of clean room class 10 0000 with all facilities to avoid air contamination.

Are the floors, walls, ceilings and windows in production areas designed/constructed for easycleaning and, if necessary, sanitization? Are the floors, walls, ceilings and windows in production areas kept clean and in good repair?

1) Photograph production area.

Are adequate, clean, washing and toilet facilities provided for personnel?

Is there adequate lighting, that is sufficient for operations, installed in all areas?

Photograph following areas: 1) Warehouse for raw material. 2) Warehouse for finished product. 3) Production areas 4) Quality Control area. 5) Dressing areas 6) Hand washing area. 7) Toilets area

Is the factory floor and area:a) Safe for production?b) Kept in clean and hygienic condition?c) Designed to prevent the risk of mix-up of products, raw materials and packaging materials?

Yes, adequate, clean, washing and toilet facilities provided for personnel. Accessibility is adequate. Air shower rooms are installed. Changing rooms are provided.

1) Record of ligh intensity. 2) Device to measure light

(The washing and toiletfacilities should be differentiated from, but accessible to, production areas. Adequate facilities for showeringand changing clothes should be provided when appropriate.)

1) Note what ventilation system. 2) Record of air change.

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Are measures taken to control the exterior of the premises to prevent attracting or harbouringpests?

Yes, there are pest tracking systems.

Is the premises designed, constructed and maintained so as to restrict access to insects, birds, rodents, pests and other vermin?

Are there cleaning / sanitization programmes and SOPs defined for each area/

Pest Control

Equipment

Yes, SOPs are posted in respective places (See photo 12, 14)

Yes, premises is design according to clean room requirement of level 100000 class. Doors are blocked with wood pallets to avoid rodents and pests going inside. Windows are closed. (See photo 23)

FRESH HAND SOAP Specific agents are used for sanitizing area and people (See photo 21). 75% Alcohol is used at hand washing station and in workshops with expiration date controlled (See photo 22)

Yes, cleaned regulary, with vacumm cleaning system. Record of cleaning is available. (See photo 8)

Yes, cleaning and necessary sanitization can be done, after removing a section of the machine. They do it after completing each job daily. (See photo 25)

Yes, the production system is divided according type of process and separated to avoid contamination between prcesses.

1) pest track system

1) Review SOPs, not document number if any.

1) What type sanitizing agents are used? 2) Is their use planned?

Calibration

Is equipment cleaned and, if necessary, sanitized and maintained?

Is there a pest control programme appropriate for the premises?

1) Cleaning / maintenance record.

1) Check if doors / windows of the premise well closed

Are cleaning and, if necessary, sanitizing agents, which are used, specified and effective?

Does the design and the installation of equipment allow ease of drainage in order to facilitate cleaning and sanitization?

Yes, there is a pest control program defined in the procedure MX-2-XZ-010, and it in posted on-site.

1) Write the document number, rev. 2) Where is it posted?

Is production equipment designed to prevent contamination of the product?

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Maintenance

Yes, there is a maintenance program for all equipment. And a maintenance program for the facility.

Have cleaning and sanitising agents been specified?

1) check if the correct cleaning agenst are used

FRESH HAND SOAP Specific agents are used for sanitizing area and peoples (See photo 21). And alcohol of 75% are used at hand washing and workshop with expiration date controlled (See photo 22)

1) photograph cleaning record. 2) check if lot number / date are mentioned in the record.

Yes, the schedule is planned in the file calibration plan.

1) Photograph Calibration plan 2) Photograph calibration cert. 3) Note the calibration date, and cert. number.

Yes, there is a calibration program listed in the file HYM-JL-C05-01-02 (See photo 24) The certificate Number HYM-201608028 with next calibation date in 2017-080-07 (See photo 26)

If results of calibration are out-of-acceptance criteria, are the measuring instruments appropriately identified and removed from service?

Is there an appropriate cleaning and, if necessary, sanitisation programme for all equipment / devices and plants?

Is there any maintenance for the equipment / plants?

Yes, according to the requirements of procedure, MX-2-PG-058, production lots inspected by the out-of-calibration equipment are investigated. As per the record, such a case has never occurred.

Is the equipment / the plant cleaned and, if necessary, sanitised at appropriate intervals in continuous production?

1) Cleaning / maintenance record.

Are laboratory and production measuring instruments that are important for the quality of the product, calibrated regularly?

Yes, appropriate cleaning and, if necessary, sanitisation programme for all equipment / devices and plants. Records of cleaning are available.

1) Doc of procedure / SOP. 2) If such case happened, please photograph the record.

1) Maintenance program for equipment. 2) Maintenance program for the facility.

1) Doc of procedure / SOP. 2) If any, photograph identification label

Yes, according the requirement of procedure MX-2-PG-058. Status of calibration on each equipment is expressed with calibration tag visible on each machine (See photo 26)

If there is an instrument in out-of-calibration condition is it investigated to determine if there is any impact to the quality of the product and appropriate steps taken based on this investigation?

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Work Instructions for maintenance of equipment is listed on the same template where records of maintenance are written.

Is it ensured that the maintenance operations do not affect the quality of the product?

Are incoming inspections conducted on purchased raw material?

Yes, WI for incoming inspections of raw material is document, for example MX-2-PG-020/021/022/023/024/025/026. Records of inspections are documented in sheet Q/MX 308011 for Raw material of Order 2017-218, inspected in 2017-7-17 (see photo 27).

Yes, sample plan and AQL defined and used sheet Q/MX 308011 (See photo 27)

Is there a process to evaluate and select appropriate suppliers / producers of materials?

Yes, the procedure MX/GMPC-QM-001, Rev A/0. 2) Lits of selected suplier is available, but there is no signature of an authorized person on it (See photo 28)

Are Sampling plans and AQL defined for incoming inspection of raw material?

Yes, machines that are not used are identified with a no-use label.

Are adequate alternative systems (backups) available to continue the processes in the event of a failure or breakdown?

Yes, each operator monitor his machine

Are there any agreements with the supplier / producer which define, for instance, the acceptance criteria, actions in the case of defect or modifications, transport conditions?

Are the equipment or production systems and control systems used in production and monitoring / control only used by authorised personnel?

1) Maintenance Work Instruction / procedure.

1) Sample plan defined? 2) AQL defined?

1) Procedure (Doc, Rev) 2) Photograph list of suppliers

Are defective parts of equipment / plants identified, marked, excluded from use and isolated if possible?

1) Photograph label placed on defective equipment

1) Work Instruction for Incoming material. 2) Photograph record. 3) Record material name / lot number if any, date.

Raw Materials and Packaging Materials

Yes, there are enough machines to act as backups.

1) Review quality agreements for key material. 2) Record name of suppliers reviewed. Photograph the agreement signed by both parties.

Yes, acceptance criteria are defined in the quality agreement signed by both parties. 2) Two suppliers were reviewed, records of their assessment are maintained on the sheet MX-CG-004 (See photo 28). 3) The annual performance in (photo 30)

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Is an adequate system used to re-evaluate and assessthe materials after a defined period of storage?

1) Procedure / SOP number. 2) Explain the system procedure

Yes, the storage period is documented in the label and they inspect it for each shipment record.

Production

Are the raw materials provided with labels which contain information on the supplier / producer, identity and badge?

Identification and Status

1) Photograph the label on raw material.

Yes, the procedure is MX-2-PG-063, Rev A/0. Identifiable labels are posted on each material on-site (See photo 31)

1) photograph the FIFO system used. Yes, they ship production following the client PO number.

1) Photograph the label of "Accepted", "rejected" or "quarantined". 2) Photograph the area where it stored.

Yes, material that is retained for futher decision is placed in a separate place. It was discovered that a paper, size A4, with the words "PENDING FOR DECISION" was posted in one place.

Storage

Are the materials storedclosed and off the floor (eg on pallets)?

1) Photograph the warehouse Yes, storage conditions are appropriate. (See phtoo 33)

Are incoming goods withvisible defects that might affect product quality retained pending a decision on their use?

1) Photograph the label of Non-conforming raw material. 2) Photograph the area where they are stored.

Yes, there is an area for material that is retained for futher decision to be placed separately (See photo 32)

Are the materials identifiedphysically as “accepted”, “rejected” or “quarantined” or is this ensured by another system with the same level of assurance?

Does the FIFO principle(First In First Out) apply for the use of the materials?

1) Photograph the warehouse Yes, materials are stored in cartons placed on pallets.

Are the raw materialslabelled with information on the container number, amount, gross / tare weight?

1) Photograph the label on raw material.

Yes, Identifiable labels are posted on each material on-site, with information of type of material, inspection date and lot number. For example of material Lot number MXY2016818, Inspected in 2016-8-22 (See photo 31)

Are the storage conditions appropriate for the materials?

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Are In-Process parts identified with a label/tag?

1) SOP for in-process inspection.

Records of IPQCs are documented, for example of IPQC conducted in Client's Order 17152, Lot number MXC20170720A, produced in date 2017-7-15 (See photo 36)

Are the in-process controls and their results documented?

Bulk Product Storage

Are any results outside theacceptance criteria reported and appropriately investigated?

1) How does deviations reported?

Yes, results of NCF are recorded in sheet Q/MX308013, for example of record fo date 2017-7-20 (See photo 37)

1) Review record of IPQC at each stage. 2) Photograph one of them. 3) Note part inspected, date and lot number in production.

Is there an established Control Plan for production?

Is each stage of manufacturing operations documented in the production record?

1) Review production flow chart. 2) SOP for each stage.

Does every batch of bulk product (eg filling product) have a batch number?

1) Photograph label on each batch on-site. 2) Note the batch / lot number

Yes, each batch in production is identifiable with a lot number, for example of Production Order Number 2017218 of part numner MX017, with lot number MXF2017.07.12 (See photo 35)

Is the production area freefrom materials from previous operations (“line clearance”)?

Yes, the production place is completely free of any material from previous production.

1) Yes, there is a production flow chart that describes each step of manufacturing process. 2) SOPs are posted at respective steps / workplaces where necessary (See photo 34)

1) Review the control plan, photograph it.

Yes, inspection plans are defiined in file MX-2-PG-001 ¬ 010.

1) Photograph label on each bacth on-site. 2) Note the bacth / lot number

Yes, for example of Production Order Number 2017218 of part number MX017, with lot number MXF2017.07.12 (See photo 35)

Have in-process controls with their acceptance criteria been defined?

Yes, there are SOPs for in-process inspection in file MX-2-PG-019 / 020 / 021 / 022 / 023 / 024 / 025 / 026 / 027 / 028 / 029 / 030.

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Finished Products

Are finished products controlled in accordance with established test methods prior to being placed on the market?

Is there a defined procedure if this duration is exceeded? 1) procedure number

Is any coding available topermit identification of the product?

1) Bar code system, tags on product, etc.

Yes, each product has a bar code printed on it already, with lot number in the inner carton.

Packing Operations

Yes, the procedure that explains duration control is in file MX-2-PG-095, Chapter 3.

1) Record of out-going inspection

Yes, each finished product is inspected as part of outgoing inspection for each lot according to a defined sample plan and AQL level.

Packaging SOPs are provided by client for each order, and are available at the packaging area.

Are bulk products stored in suitable containers, in defined areas and under appropriate conditions?

Yes, products are stored in carton as defned by the client order, and placed on pallets. The finished products, ready for shipment, are placed in warehouse.

Has a maximum bulkproduct storage duration been defined?

1) Storage condition

2) Note storage time

Yes, each product has an expiration date. Each warehouse has a device to keep storage condition in normal env.

Is each stage of packaging operations documented in the manufacturing record?

1) Packaging work instruction

Yes, procedure MX-2-PG-095 prescribes storage conditions, and appropriate durations of storage. Each product has a label that indicates production date and expiration date.

Have in-process controls and their acceptance criteria been defined during packaging?

Yes, they are defined.

Are there any specifications for finished products including acceptance criteria?

1) Work Instrcuion for FQCYes, there are SOPs / specifications for finished products, as per procedure MX-2-PG-059.

Is the product release carried out by the authorised personnel responsible for quality?

1) Check there is a signature of an authority in the FQC / OQC record.

Yes, the product release is under responsibility of the Quality Manager as authorised personnel. QC personnel conduct the outgoing inspection.

Are finished products stored in defined areas under appropriate conditions and for an appropriate length of time?

1) Storage period system

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8.0.5 C

9

9.0.1 C

9.0.2 C

9.0.3 C

9.0.4 C

9.0.5 C

9.0.6 C

10

10.0.1 C

10.0.2 C

Are the samples of finished products retained in an appropriate manner and in designated areas?

Does the quality control laboratory use all test methods which are necessary to confirm that the product complies with the acceptance criteria?

Review record, note lot number of material tested, date, tester…etc

Are the types of waste for the given production processes that could affect the quality of the finished products defined?

List of type of waste from production, and control method

Yes, there is a waste management procedure, MX-2-PG-026, in which arrangements for waste control are defined.

Waste Control

Is there clear traceability of inspecton results?

Yes, traceability of test results are maintained, per lot number of incoming material.

Are wastes disposed of in a timely and sanitary manner?

Procedure for waste control, document number

Yes, there is a program for waste disposal.

Yes, necessary methods used for testing.

Are the laboratory results documented & reviewed? Test methods, records Yes, records of results are maintained.

Test methods, records

Procedure MX-2-YW-004 indicates practices for recall. Practice of recall documented. For example, in 2016/7/23 product of lot number 2016129 complaint received in 2016/7/21 at 18:00. Product Model 10M.

Sample retention place, period, identification…etc

status of cleanliness, maintenance, identification, skill matrix…etc

Work Instruction

Quality Control Laboratory

Yes, samples are maintained

Is the quality controllaboratory responsible for sampling, controls and releases according to defined acceptance criteria?

Do the principles described for personnel, premises, equipment, subcontracting and documentation also apply to the quality control laboratory?

Yes, cleanliness requirements, env. control are the same. However, the lab center is not considered as a cleanroom since it is located off that premises, in another building.

Are finished products whichare released, quarantined or rejected, stored in their respective physical locations or is a data system available which ensures segregation?

Yes, the factory has different areas to store finished products depending on the quality status.

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10.0.3 C

10.0.4 C

11

11.0.1 N/A

11.0.2 N/A

11.0.3 N/A

11.0.4 N/A

12

12.0.1 C

12.0.2 C

12.0.3 C

13

Non-conforming products

Complaints and Recalls

Are the corrective measuresimplemented in such a way that recurrence of non-conforming products is avoided?

Record of corrective action in few deviations.

Yes, reviewed 3 cases of NCFs found at the final inspection. For PO 2016425, 2016458 and 16228 (See photo 39)

Are measures available which regulate the approach in the event of non-conformities from specified requirements?

Procedure to solve NCF/ deviation in product or process

There is a procedure to control NCFs MX-2-PG-057, Rev A/0

Are sufficient data availablefor the decision about a possible correction?

Log of NCF / deviation

Yes, information is available for potential root cause investigation and respective corrective action. Products are inspected 100% before packaging, and all NCF parts are identified and then recorded on a sheet (See photo 37). Those data are expressed in a graphical manner to display the deviation (See photo 38).

Are the duties and responsibilities (delimitation of obligations / responsibilities, “matrix”) of the two parties defined in the contract?

Review the contract The factory has no service to subcontract, Not applicable

Does the contract acceptorinform the contract giver of any planned changes that may affect the quality of the services or products?

Is this mentione din the contract? The factory has no service to subcontract, Not applicable

Are subcontracting / services and contract manufacturing defined in a written contract?

1) Procedure for sub-contracting. The factory has no service to subcontract, Not applicable

Subcontracting Manufacturing

Are checks and audits by the contract giver at the contract acceptor contractually fixed?

1) record of last check/audit The factory has no service to subcontract, Not applicable

Are the individual measuresof collection, transportation, storage and disposal of wastes adequately documented?

Yes, each workshop has a specific box for collection of waste. And waste is collected every day and taken off the premises.

Are the containers of waste properly identified (possibly with additional information)?

Photograph containers of waste Yes, containers of wastes are available at each workshop.

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13.0.1 C

13.0.2 C

13.0.3 C

13.0.4 C

13.0.5 N/A

13.0.6 N/A

13.0.7 C

14

14.0.1 C

Yes, there is a prevision to review the trends, and data is available.

Has a process been defined for changes (plants, material, process etc.) which could affect the quality of the product?

Procedure to handle change

Yes, there is a procedure for change control MX-2-YW-001, Rev A/0. Change often happens in raw materials, quality in the client PO…etc.

Change Control

Is the product recall processevaluated periodically?

Procedure MX-2-YW-004 indicates the practice for recalls. The recall of products is documented, for example, on 2016/7/23 product with lot number 2016129, complaint recall received on 2016/7/21 at 18:00. Product Model 10ML of logo Charlene, client Number MX163.

Are recalled products storedseparately in a secure area while awaiting a decision?

A recall has never occurred.

Are all complaints that fall within the scope of these guidelines and are communicated to the plant reviewed, investigated and followed up, as appropriate?

1) Procedure for complaint.

Yes, the procedure is MX-2-YW-005, Rev A/0. Reviewed 3 cases of complaints. For example PO 2016153, MX2016435, MX2016378, MX2016349 (See photo 40)

Are appropriate steps takenin the event of a product recall decision in order to complete the recall within the scope of these GMP guidelines?

1) Procedure of recall 2) Record of recall and actions.

Yes, there is a procedure for the recall MX-2-YW-003, Rev A/0, and procedure MX-2-YW-004 applies to the practice of the recall procedure.

In the case of a productrecall decision, are corresponding corrective and preventive measures initiated?

Are product recalloperations initiated promptly and in a timely manner?

A recall has never occurred.

Record of corrective action for a recall decision.

Yes, respective corrective action is required in the procedure MX-2-YW-003, in chapter 3.8, page 3/4

Are complaints reviewedperiodically to check for trends or recurrence of a defect on a precautionary basis?

Pareto graphic for complaint.

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14.0.2 C

14.0.3 C

15

15.0.1 C

15.0.2 C

15.0.3 C

15.0.4 C

15.0.5 C

15.0.6 C

Are changes performed by adefined authorised personnel?

Yes, it is planned that when a change request comes from the client. They will review the request and inform the client about the approval to implement the change.

Does the duration ofarchiving correspond to the applicable legislation and internal regulations?

Yes, the retention of document / record following the requirement of ISO 22716:2007

Does the documentationsystem include all instructions, specifications, test protocols, reports, methods and records appropriate to the activities covered by the GMP guidelines? (as hard copy paper or electronic data processing record)

1) Review DMR files 2) Procedure for control of DMR file.

Yes, the documentation includes all DMR files, operational procedures, maintenance SOPs. All defined as per GMP for cosmetic product requirements.

Do the defined documents describe the corresponding operations to be carriedout, precautions to be taken and measures to be applied with appropriate detail?

Procedure for document control/change. Record of change.

Yes, documents are updated when applicable, and distributed following requirements of the document control procedure.

Documentation

Are documents, where necessary, updated and is the reason for revision and number and / or reason for the revision and version number stated?

Are the stored / saved documents (in paper or electronic form) legible and secured?

Yes, documents are stored on paper, are legible, and they are stored at the quality department office with secured access.

Yes, there are SOPs for inspection in files MX-2-PG-019 / 020 / 021 / 022 / 023 / 024 / 025 / 026 / 027 / 028 / 029 / 030.

Are the changes documented? Record of change (plants, material, process etc.)

Yes, in sheet MX306001-2017, for example of client MX020 for PO number 2017192

Does the company have an adequate system of documentation established and implemented that is appropriate to its organisational structure and type of products, and does it maintain such a system?

1) Quality Manual 2) List of applicable procedures

1) Yes, the organization has a Quality Manual MX/GMPC-QM-001, published since 2015, to meet requirements of ISO 9001:2008, ISO 22716:2007, FDA-GMPC and EEC 2) The factory established a list of applicable procedures to support the implementation of the commitment outlined in the Quality Manual.

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5. Training record of new employee 6, 7. Machine cleaning

Supplier Name Audit Date Report No.XXXXXXXXXX XXXXXXXXXX

2. Cosmetic product in Showroom

3. Training program for year 2017


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4. Record of training

1. Factory Building


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11, 12 Hand washing facilities and instruction 13. Employee wearing clothes

9. Record of air conditioner cleaning 10. Job Description

14. SOPs and cleaning Wis 15. Heath Certificate of employees

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16. Leave record of employee in illness condition 17. Signature of commitment of visitor

18. Producti9on area 19. Warehouse for Raw Material

20. Certificate of conformity of Cleanroom 21. Cleaning agents usedfor hand washing

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22. 75% Acohol agents used at hand washing 23. System to avoir pest enter in the workshop

25. Record of incoming inspection of Raw Material 27. Identification of Raw Material in warehouse

24. Calibration plan 26. Calibration certificate + tags on equipment.

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30. Annual performance of supplier 31. Quality Status of Raw Material, with Green label

28. List of qualified suppliers 29. Record of initial evaluation of supplier

32. Raw Material waiting for further decision 33. Packaging process

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41. ISO 22716 : 2007 Certificate 42. Certificate of FDA conpliance.

39. Record of CAP from internal NCFs 40. Record of CAP from external client's complaint

Documents

GMP Audit Cosmetics Products - proqc.com · The factory has been certified to ISO 22716: 2009 for cosmetic products by SGS since 17th Sep, 2016 ... implement Good Manufacturing Practices?