Iso 22716 gmp white paper

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Lakshy Management Consultant Pvt. Ltd.

COSMETIC GOOD MANUFACTURING PRACTICE – ISO 22716

Lakshy Management Consultant Pvt. Ltd.:- 229, Sai Chambers, Sector 11, CBD Belapur, Navi Mumbai 400614, India – R00-200310

I 24 Hours Customer Care: +91 9821780035 I Phone +91 32995241 I Web: www.lakshy.com I Email: [email protected] I

WHAT IS ISO 22716?

One of the pillars of the EU cosmetics Regulation, ISO

22716:2007 gives guidelines for the production, control,

storage and shipment of cosmetic products.

To ensure Consumer Safety, cosmetic products placed on the

EU market should be produced according to good

manufacturing practice (GMP)

The objective of the GMP is to define the activities which lead

to the final product corresponding to the expected

specifications, and therefore product safety

Providing ISO 22716 consulting and Training services

across the world.

ISO 22716 - Cosmetics Good Manufacturing Practices

Cosmetics Good Manufacturing Practices are a set of

hands-on advice, operational rules and

organizational guidelines especially focused on

human, technical and administrative factors

affecting product quality.

ISO 22716 is the standard describing the Cosmetics

Good Manufacturing Practices. It has been written in

collaboration with cosmetics industry professionals

and promotes best-in-class methods.

Scope of ISO 22716 is not only limited to production

activities but also includes control, storage and

expedition.

Eight Hygiene Principles






What does Lakshy Management Consultant Pvt. Ltd. Offers in the field of ISO 22716 Good Manufacturing Practices?

The quality management professionals at Lakshy have considerable experience helping our clients to design and implement ISO 22716 Good Manufacturing Practices. Lakshy offers comprehensive services that will help you achieve your ISO 22716 Good Manufacturing Practices goals. We can:

• Conduct an initial gap analysis

• Help you establish policies and objectives.

• Identify documentation requirements

• Coordinate document preparation, reviews, approvals, and issuance.

• Manage implementation schedules, training, follow-up actions

• Help you select a Registrar that has experience in your industry and achieve successful accreditation.

In addition to consulting (onsite and online), we provide following training

• ISO 22716 Overview Training

• ISO 22716 Good Manufacturing Practices Training

• ISO 22716 Internal Auditor training

• ISO 22716 Implementation training

GENERAL REQUIREMENTS FOR ISO 22716 Good Manufacturing Practices. ISO 22716 provides guidance in a number of areas, which can be broadly divided into 5 categories:

• Personnel • Premises and equipment • Production • Quality control • Quality systems

Benefits of ISO 22716 - Cosmetics Good Manufacturing Practices.

Benefits from a proactive approach to a compliant GMP program include:

• Validation of conformity of the Management System with the new legal requirements

• Helping customers, employees, stockholders, regulators and competitors develop sustainable respect for an

organization which demonstrates commitment to GMP.

• Operating costs drop as rework and penalties due to non-compliance reduce and efficiencies increase.

• Improved Product Consistency

• Ensure access to European and World wide Markets

• Inspire consumers’ confidence

• Enhance operating efficiency and competitive market appeal

• Help customers, employees, stockholders, regulators and competitors develop sustainable respect for an

organization which demonstrates commitment to GMP.











Steps To Establishing An Effective GMP

1. Top Management commitment. 2. Define responsibilities, trainings on GMP importance, Monitoring of Hygiene and Health. 3. Monitoring of the Premises, Lighting, Ventilation, Sanitation. Ensuring daily cleaning and regular Maintenance

and Calibrations of Equipments. 4. Ensure purchasing of Raw Material, packaging Material from Approved Suppliers, Identification and Labelling of

Raw Material and ensure proper Storage System Implemented.

5. At each stage of manufacturing operations and packaging operations, measures should be taken to produce a

finished product of good quality

6. Storage, shipment and returns should be managed in a manner so as to maintain the quality of finished

products.

4. quality control laboratory should use all measures necessary to confirm that the product complies with

acceptance criteria.

5. Checking—develop processes for monitoring & measurement & corrective & preventive action

6. Establish internal audit program, including training; conduct initial internal audit to evaluate conformity to

requirements of GMP

7. Final Certification Audit.






With a team of highly qualified consultants and trainers having vast industrial experience, we partner organizations across

the world to implement and achieve ISO 22716 Good Manufacturing Practices.

Our consulting approach is highly professional, time bound and effective resulting in ease of implementation and adds

value to the business processes of the client organization.

Contact us at [email protected] to get your organization ISO 22716 Good Manufacturing Practices Accredited.

Documentation

ISO 22716 requires different types of documentation as illustrated in the documentation pyramid below.

A policy documents the intent and goal of the organisation to conform to ISO 22716 Requirements Quality manual describes the approaches to achieve quality data. It includes quality policy. A process describes how various quality requirements can be achieved. Standard operating procedures or working procedures are step by step instructions on how to exactly

perform a specific task. Records are generated on day by day basis. All records should be well controlled.

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Iso 22716 gmp white paper