4.guide to gmp for medicinal products(pic

7/29/2019 4.Guide to GMP for Medicinal Products(PIC

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Guide to GMP for Medicinal Products(PIC/S)


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Download Guideline PIC/S GMP www.picscheme.org

PUBLICATIONS

PIC/S GUIDE

PE009-2

GUIDE TO GOOD MANUFACTURING

PRACTICE

FOR MEDICINAL PRODUCTS


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1. 143 A4

2. 1 ( INTRODUCTION )

9

(CHAPTER)

18 (Annex)


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PIC/S AND EU GMP

CHATER 1 QUALITY MANAGEMENT

CHATER 2 PERSONNEL

CHATER 3 PREMISES AND EQUIPMENT

CHATER 4 DOCUMENTATION

CHATER 5 PRODUCTION

CHATER 6 QUALITY CONTROL

CHATER 7 CONTRACT MANUFACTURE AND

ANALYSISCHATER 8 COMPLAINTS AND PRODUCT

RECALL

CHATER 9 SELF INSPECTION


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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 immunologicalsAnnex 5 Manufacture of immunological veterinary medical

products

Annex 6 Manufacture of medicinal gasesAnnex 7 Manufacture of herbal medicinal products

Annex 8 Sampling of staring and packaging materials

Annex 9 Manufacture of liquids, creams and ointments


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Annexes

Annex 10 Manufacture of pressurised metered doseaerosol preparations for inhalation

Annex 11 Computerised systems

Annex 12 Use of ionising radiation in the manufactureof medicinal products

Annex 13 Manufacture of investigational medicinalproducts

Annex 14 Manufacture of products derived from humanblood 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 pharmaceuticalingredients


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

INTRODUCTION

In order to further facilitate the removal of

barriers to trade in medicinal products, to promoteuniformity in licensing decisions and to ensure the

maintaining of hight standards of quality assurance in

the development, manufacture and control of medicinalproducts throughout Europe, it was agreed to

harmonize the rules of GMP applied under

Pharmaceutical Inspection Convention(PIC) and thePharmaceutical Inspection Co-operation Sheme(PIC/S)

to those of the EU Guide to Good Manufacturing

Practice for Medicinal Products and its Annexes.


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

INTRODUCTION

CHAPTER 1 - QUALITY MANAGEMENT

PrincipleQuality Assurance

Good Manufacturing Practice for Medicinal

products (GMP)Quality Control

CHAPTER 2 - PERSONNEL

PrincipleGeneral

Key Personnel

TrainingPersonal Hygiene


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

CHAPTER 3 - PREMISES AND EQUIPMENT

Principle

PremisesGeneral

Production Area

Storage Areas

Quality Control Areas

Ancillary Areas

Equipment


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

CHAPTER 4 - DOCUMENTATION

Principle

GeneralDocuments required

Specifications

Specifications for starting and packaging

materials

Specifications for intermediate and bulk

products

Specifications for finished products


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

Manufacturing Formula and Processing

Instructions

Packaging InstructionsBatch Processing Records

Batch Packaging Records

Procedures and records

Receipt

Sampling

Testing

Other


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

CHAPTER 5 - PRODUCTION

Principle

General

Prevention of cross-contamination inproduction

Validation

Starting materialsProcessing operations - Intermediate andbulk products

Packaging materials

Packaging operations

Finished products

Rejected, recovered and returned

materials


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

CHAPTER 6 - QUALITY CONTROL

Principle

General

Good Quality Control Laboratory Practice

Documentation

Sampling

TestingCHAPTER 7 - CONTRACT MANUFACTURE AND ANALYSIS

Principle

GeneralThe Contract Giver

The Contract Acceptor

The Contract


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

CHAPTER 8 - COMPLAINTS AND PRODUCT RECALL

Principle

ComplaintsRecalls

CHAPTER 9 - SELF INSPECTION

Principle


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CHAPTER 1

QUALITY MANAGEMENTThe holder of a manufacturing authorisation must

manufacture medicinal products so as to ensure thatthey 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.


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To achieve the quality objective reliably there must

be a comprehensively designed and correctly

implemented system of Quality Assurance

Incorporating Good Manufacturing Practice and thusQuality 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 1

QUALITY MANAGEMENT


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CHAPTER 2

PERSONNELThe 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 sufficientqualified 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.


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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 2

PERSONNEL


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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.


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CHAPTER 4

DOCUMENTATIONGood 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.


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CHAPTER 5

PRODUCTIONProduction 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.


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CHAPTER 6

QUALITY CONTROLQuality 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.


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CHAPTER 7

CONTRACT MANUFACTURE AND ANALYSISContract manufacture and analysis must be correctly

defined, agreed and controlled in order to avoidmisunderstandings 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.


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CHAPTER 8

COMPLAITNS AND PRODUCT RECALLAll complaints and other information concerning

potentially defective products must be carefullyreviewed 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..


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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 T h i l R t S i N 908 2003


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WHO Technical Report Series, No. 908, 2003

Annex 4 : Good Manufacturing Practices forpharmaceutical 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


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4. Qualification and validation

5. Complaints

6. Product recalls

7. Contract production and analysis

General

The contract giver

The contract accepter

The contract



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8. Self-inspection and quality audits

Items for self-inspection

Self-inspection teamFrequency of self-inspection

Self-inspection report

Follow-up action

Quality audit

Suppliers audits and approval9. Personnel

General

Key personnel



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10. Training11. Personal hygiene

12. Premises

GeneralAncillary areas

Storage areas

Weighing areasProduction areas

Quality control areas

13. Equipment



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14. MaterialsGeneral

Starting materials

Packaging materialsIntermediate and bulk products

Finished products

Rejected, recovered, reprocessed andreworked materials

Recalled products

Returned goods

Reagents and culture media

Reference standards

Waste materialsMiscellaneous



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15. DocumentationGeneral

Documents required

16. Good practices in productionGeneral

Prevention of cross-contamination andbacterial 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 reviewStability studies

References


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