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Materials/Standards
Supaporn PhumiamornDivision of Biological Products
GMP course, 17-18 Jan, 2006
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 2
Type of materials
Starting materials Packaging materials Intermediate and bulk materials Finished products Rejected and recovered materials Returned goods Recalled products
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 3
Reagent and culture media Reference standards Waste materials Miscellaneous materials
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 4
General requirements for materials
All incoming materials and finished products- quarantined after receipt
- until release for use - distribution
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 5
Stored- under appropriate condition-orderly fashion (batch segregation)- materials management-stock rotation (FIFO, FEFO)
General requirements for materials
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 6
• Documentation
- SOPs- Records- Labels- Specifications
General requirements for materials
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 7
Starting materials Purchasing Suppliers Consignment
- integrity - delivery note- seal - supplier’s label- order
Cleaned and labeled
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 8
Damaged containers Starting materials label:
- name and internal code- batch number- status- expiry date or re-test date
Sample container identified
Starting materials
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 9
Use only released material Dispensing
- designated persons- written procedure- accurately weighed- clean, labeled containers
Starting materials
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 10
Independent checks- material and weight
Dispensed material- kept together and labeled
Starting materials
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 11
Why starting materials are so important?
Because their quality can directly
affect the quality of finishedproducts
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 12
Packaging materials
Primary and printed materials:- as for starting materials
purchasing, handing and control No unauthorized access Storage and transport
- avoid mix-ups- issue and return: SOP
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 13
Intermediate and bulk products
Appropriate conditions
Purchased:-as starting materials
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 14
Finished products
Quarantine until released
Storage conditions
Evaluation and documentation- product release
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 15
Rejected and recovered materials
Rejected materials- clearly marked- stored separately in restricted areas- take action rapidly
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 16
Reprocessing- exceptional- procedure and records- batch number- additional testing
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 17
Recovery- prior authorization- additional testing
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 18
Recalled products and returned goods
Recalled products- identified-stored separately- access controlled
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 19
Returned goods- SOP: decision regarding the fate- nature of product, storage conditions- history, time lapse- records
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 20
Reagents and culture media
Record upon receipt or preparation Reagents:
- preparation in accordance with SOP- label:
- concentration, shelf-life, storage conditions
- signed and dated
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 21
Culture media:- positive and negative controls
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 22
Standard must be stable Sufficient standard must be
available for several years
Reference Standard
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 23
Secondary or working standards:- appropriate checks and tests- regular intervals- based on official reference standards
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 24
WHO Expert Committee on Biological Standardization (ECBS)
One of the oldest WHO committees Began as a mechanism for developing
primary biological standards Meet each year in Geneva Members chosen from the Expert
Advisory Panel Reports published in WHO Technical
Report Series
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 25
Purpose - To establish primary biological standards - To prepare written guidance on
production and quality control of biological medicinal products
- To develop international consensus on issues of quality, safety and efficacy related to biological products
WHO Expert Committee on Biological Standardization (ECBS)
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 26
Biological reference materials
Standard and test must be similar in composition and behave in the same way in the test system
Standard does not have to be pure
Standard must have potency value assigned
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 27
Calibration System
WHO: Calibration is generally achieved by parallel titration on at least six separate occasions.
NCL: Calibration is routinely performed atleast six times by at least two
persons. (2 NCL labs + Manufacturer lab)
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 28
Calibration of WRP for Total OPV
กราฟแสดงผลการสอบเที�ยบOPV: Total
6.2
6.4
6.6
6.8
7
1 2 3 4 5 6ครั้��งที่��
log CCID50/ dose Potency
Mean
Mean+2SD
Mean-2SD
Mean+3SD
Mean-3SD
(Measles, Mumps, Rubella)
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 29
Parallel line assayR
esp
onse
Dose
Parallelity
Linearity
95% confidence limit
Probit analysis
(JE, Rabies ,Hepatitis B, Pertussis vaccines)
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 30
Reference Standard materials
assuring the uniformity of the testing results
assuring the reliability of the testing resultsassuring the reliability of the testing results
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 31
Waste materials and miscellaneous materials
Waste materials- proper and safe storage- toxic and flammable materials
- separate, enclosed, as per legislation- not allowed to accumulate
- collected for safe disposal- regular intervals
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 32
Miscellaneous- rodenticides, insecticides, sanitizing materials- contamination risks
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 33
Materials checklist Quarantine Storage condition Purchasing Labelling Use of release material Printed packaging material Purchasing of intermediate or bulk
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 34
Materials checklistRecords of the original and history of seeds/ banks and etc.
Specifications for biological additives-Trypsin is mycoplasma free- Fetal calf serum if from BSC free animals
Certificate of analysis from the supplier
Records of audit of supplier
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 35
Warehouse area Entering Sufficient capacity Good storage conditions Sanitation program Receiving and dispatch bays Quarantine areas Sampling areas Segregation
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 36
Highly active and hazardous materials Handling and distribution Contanmination and cross-contamination The First Expired/First Out (FEEO) Rejected materials Narcotic Damaged items
Warehouse area
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Warehousing and Distribution
Products
Quarantine
Quality control
Release - FIFO- FEFO
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Storage conditions
Stability Monitoring
- Check and record- Records- Equipment calibration
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 39
Documentations and records
SOPs and Records Written information Container’s label
- Name- Lot number- Shelf life- Storage conditions
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 40
Receipt of incoming materials
Check against the relevant purchase order
Uniformity Container inspection Record should be retained for each
delivery Sampling Quarantine and batch segregation Written release or rejection Rejected materials cannot be used
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 41
Stock rotation and control
Comprehensive records Periodic stock reconciliation Significant stock discrepancies Re-close and reseal Damaged containers Outdate materials
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Dispatch and transport
Integrity Special care for dry ice Delivery order Rules for dispatch The outside container Monitor conditions during
transportation
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 43
Warehouse check list
Identification of all customers
Records of storage: time, temperatures
Records of date, quantity, mode of packaging
Distribution to customer
SOPs for storage of released products
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SOPs for warehousing
SOPs for shipping, final transit conditions and storage
Validation and monitoring of shipping methods
Recalled
Maintenance of records for 2 years beyondExpiry date
Supaporn Phumiamorn,GMP course 17-18 Jan,2006 45
References
WHO,1997. Joint training on GMP for biological products in Thailand, 2-11 September, 1997
Chung Keel Lee, 2003. GMP and related topics, 13-15 October, 2003.
Chung Keel Lee, 2004. Current GMP for biological products and its practical implementation, 22-23 March, 2004.
FDA and WHO, 2004. GMP inspection workshop, 21-29 June, 2004.