Guide to GMP for Medicinal Products(PIC/S)

Guide to GMP for Medicinal Products(PIC/S)

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PUBLICATIONS PIC/S GUIDE PE009-2 GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS

Guide to GMP for Medicinal Products(PIC/S)

1. 143 A4 2.
1 ( INTRODUCTION ) 9 (CHAPTER) 18 (Annex)

PIC/S AND EU GMP

CHATER 1 QUALITY MANAGEMENT CHATER 2 PERSONNEL CHATER 3 PREMISES AND EQUIPMENT CHATER 4 CHATER 5 CHATER 6 CHATER 7 DOCUMENTATION PRODUCTION QUALITY CONTROL CONTRACT MANUFACTURE AND ANALYSIS CHATER 8 COMPLAINTS AND PRODUCT RECALL CHATER 9 SELF INSPECTION

Annexes
Annex 1 Manufacture of sterile medicinal products Annex 2 Manufacture of biological medicinal products for human use Annex 3 Manufacture of radiopharmaceuticals Annex 4 Manufacture of veterinary medicinal products other than immunologicals Annex 5 Manufacture of immunological veterinary medical products Annex 6 Manufacture of medicinal gases Annex 7 Manufacture of herbal medicinal products Annex 8 Sampling of staring and packaging materials Annex 9 Manufacture of liquids, creams and ointments

Annexes
Annex 10 Manufacture of pressurised metered dose aerosol preparations for inhalation Annex 11 Computerised systems Annex 12 Use of ionising radiation in the manufacture of medicinal products Annex 13 Manufacture of investigational medicinal products Annex 14 Manufacture of products derived from human blood or human plasma Annex 15 Oualification and validaiton Annex 16 (Quaified person and batch release) Annex 17 Parametric release Annex 18 GMP Guide for active pharmaceutical ingredients

PIC/S : PE 009-2, 1 July 2004

INTRODUCTION In order to further facilitate the removal of barriers to trade in medicinal products, to promote uniformity in licensing decisions and to ensure the maintaining of hight standards of quality assurance in the development, manufacture and control of medicinal products throughout Europe, it was agreed to harmonize the rules of GMP applied under Pharmaceutical Inspection Convention(PIC) and the Pharmaceutical Inspection Co-operation Sheme(PIC/S) to those of the EU Guide to Good Manufacturing Practice for Medicinal Products and its Annexes.

PIC/S : PE 009-2, 1 July 2004

INTRODUCTION CHAPTER 1 - QUALITY MANAGEMENT Principle Quality Assurance Good Manufacturing Practice for Medicinal products (GMP) Quality Control CHAPTER 2 - PERSONNEL Principle General Key Personnel Training Personal Hygiene

PIC/S : PE 009-2, 1 July 2004

CHAPTER 3 - PREMISES AND EQUIPMENT Principle Premises General Production Area Storage Areas Quality Control Areas Ancillary Areas Equipment

PIC/S : PE 009-2, 1 July 2004

CHAPTER 4 - DOCUMENTATION Principle General Documents required Specifications Specifications for starting and packaging materials Specifications for intermediate and bulk products Specifications for finished products

PIC/S : PE 009-2, 1 July 2004

Manufacturing Formula and Processing Instructions Packaging Instructions Batch Processing Records Batch Packaging Records Procedures and records Receipt Sampling Testing Other

PIC/S : PE 009-2, 1 July 2004

CHAPTER 5 - PRODUCTION Principle General Prevention of cross-contamination in production Validation Starting materials Processing operations - Intermediate and bulk products Packaging materials Packaging operations Finished products Rejected, recovered and returned materials

PIC/S : PE 009-2, 1 July 2004

CHAPTER 6 - QUALITY CONTROL Principle General Good Quality Control Laboratory Practice Documentation Sampling Testing CHAPTER 7 - CONTRACT MANUFACTURE AND ANALYSIS Principle General The Contract Giver The Contract Acceptor The Contract

PIC/S : PE 009-2, 1 July 2004

CHAPTER 8 - COMPLAINTS AND PRODUCT RECALL Principle Complaints Recalls CHAPTER 9 - SELF INSPECTION Principle

CHAPTER 1 QUALITY MANAGEMENT

The holder of a manufacturing authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the marketing authorisation and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels within the company, by the companys suppliers and by the distributors.

CHAPTER 1 QUALITY MANAGEMENT

To achieve the quality objective reliably there must be a comprehensively designed and correctly implemented system of Quality Assurance Incorporating Good Manufacturing Practice and thus Quality Control. It should be fully documented and its effectiveness monitored. All parts of the Quality Assurance systems should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities.

CHAPTER 2 PERSONNEL
The establishment and maintenance of a satisfactory system of quality assurance and the correct manufacture of medicinal products relies upon people. For this reason there must be sufficient qualified personnel to carry out all the tasks which are the responsibility of the manufacturer. Individual responsibilities should be clearly understood by the individuals and recorded.

CHAPTER 2 PERSONNEL
All personnel should be aware of the principles of Good Manufacturing Practice that affect them and receive initial and continuing training, including hygiene instructions, relevant to their needs

CHAPTER 3 PREMISES AND EQUIPMENT

Premises and equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out. Their layout and design must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build up of dust or dirt and, in general, any adverse effect on the quality of products.

CHAPTER 4 DOCUMENTATION
Good documentation constitutes an essential part of the quality assurance system. Clearly written documentation prevents errors from spoken communication and permits tracing of batch history. Specifications, Manufacturing Formulae and instruction, procedures, and records must be free from errors and available in writing. The legibility of documents is of paramount importance.

CHAPTER 5 PRODUCTION
Production operations must follow clearly defined procedures; they must comply with the principles of Good Manufacturing Practice in order to obtain products of the requisite quality and be in accordance with the relevant manufacturing and marketing authorizations.

CHAPTER 6 QUALITY CONTROL

Quality Control is concerned with sampling, specifications and testing as well as the organisation, documentation and relevant tests are carried out, and that materials are not released for use, nor products released for sale or supply, until their quality has been judged satisfactory. Quality Control is not confined to laboratory operations, but must be involved in all decisions which may concern the quality of the product. The independence of Quality Control from production is considered fundamental to the satisfactory operation of Quality Control.

CHAPTER 7 CONTRACT MANUFACTURE AND ANALYSIS

Contract manufacture and analysis must be correctly defined, agreed and controlled in order to avoid misunderstandings which could result in a product or work of unsatisfactory quality. There must be a written contract between the Contract Giver and the Contract Acceptor which clearly establishes the duties of each party. The contract must clearly state the way in which the authorised person releacing each batch of product for sale exercises his full responsibility.

CHAPTER 8 COMPLAITNS AND PRODUCT RECALL

All complaints and other information concerning potentially defective products must be carefully reviewed according to written procedures. In order to provide for all contingencies, a system should be designed to recall, if necessary, promptly and effectively products known or suspected to be defective from the market..

CHAPTER 9 SELF INSPECTION

Self inspections should be conducted in order to monitor the implementation and compliance with Good Manufacturing Practice Principles and to propose necessary corrective measures.

WHO Technical Report Series, No. 908, 2003

Annex 4 : Good Manufacturing Practices for pharmaceutical products: main principles

Introduction General considerations Glossary Quality management in the drug industry: philosophy and essential elements 1. Quality assurance 2. Good manufacturing practices for pharmaceutical products (GMP) 3. Sanitation and hygiene

WHO Technical Report Series, No. 908, 2003

4. Qualification and validation 5. Complaints 6. Product recalls 7. Contract production and analysis General The contract giver The contract accepter The contract

WHO Technical Report Series, No. 908, 2003

8. Self-inspection and quality audits Items for self-inspection Self-inspection team Frequency of self-inspection Self-inspection report Follow-up action Quality audit Suppliers audits and approval 9. Personnel General Key personnel

WHO Technical Report Series, No. 908, 2003

10. Training 11. Personal hygiene 12. Premises General Ancillary areas Storage areas Weighing areas Production areas Quality control areas 13. Equipment

WHO Technical Report Series, No. 908, 2003

14. Materials General Starting materials Packaging materials Intermediate and bulk products Finished products Rejected, recovered, reprocessed and reworked materials Recalled products Returned goods Reagents and culture media Reference standards Waste materials Miscellaneous

WHO Technical Report Series, No. 908, 2003

15. Documentation General Documents required 16. Good practices in production General Prevention of cross-contamination and bacterial contamination during production Processing operations Packaging operations 17. Good practices in quality control Control of starting materials and intermediate, bulk and finished products Test requirements Batch record review Stability studies References