good practices in production and quality control. related guidelines john startup

Artemisinin based combined medicinesFebruary 23-27, 2009, Kampala, Uganda 1 |

Good Practices in Production and Quality Control Related Guidelines

Training workshop: Training workshop on regulatory requirements for registration of Artemisinin based combined medicines and assessment of data submitted to regulatory authorities, February 23-27, 2009, Kampala, Uganda.

Good Practices in Production and Quality Control.

Related Guidelines

John Startup

Good Practices in Production and Quality Control.

Related Guidelines

John Startup

JOHN STARTUP


Good Practices in Production and Quality

Control.

Related Guidelines

Basic Principles of GMP


The Ten Commandments of GMP


Section 16 and 17


The Ten Commandments of

GMP1 Build Adequate Premises

2 Equip Your Premises with plant and services fit for purpose.

3 Maintain your premises and equipment

4 Write procedures

5 Validate your work/procedures


Section 16 and 17


The Ten Commandments of GMP

6 Train your workforce

7 Record your work

8 Be clean in all things

9 Test for Quality

10 Audit for compliance.



The WHO Guidelines

EEC Guidelines(ORANGE GUIDE

Eudralex Guidelines

FDA Guidelines(CFR)

MHRA Specific Topics



Well documented and respected guidelines.

Most available on the internet (OG is the exception)



Do not forget EP, BP,USP

Setting standards as opposed to

guidelines



PREMISESEEC 1.3

Specifically Annexe 1 Sterile Manufacture

WHO Chapter 1 .12

HVAC

Chapter 3 Sterile Manufacture.

Eudralex Monograph



EQUIPMENTEEC 3 and 5 (production)

Specifically Annexe 1 Sterile Manufacture

WHO Chapter 1 (includes HVAC) Chapter 3 Sterile

Manufacture.

Eudralex Guideline. Also Sterile Manufacture.



CARE and MAINTENANCEEEC 3.34 to 3.44 Cleaning and maintenance.

WHO 1.13

Company SOP for service schedule and pre programmed

Maintenance (PPM)



WRITE PROCEDURESAddressed in the Documentation

chapters of the guidelinesEEC 4.19 to 4.29

Include but not limited to

• Inventory control

• Sampling

• Testing and status control

• Manufacture and packaging

• Hygiene /environmental monitoring & control



WRITE PROCEDURESAddressed in the Documentation

chapters of the guidelines

WHO 1.15

Eudralex

PIC Annexe 13



VALIDATIONValidation protocols usually have a

generic format #

See WHO 1 appendix 6

Validation Master Plan

PIC guideline 10063



VALIDATION“A recorded protocol which demonstrates with a high degree of probability that any activity will repeatedly produce a result within a pre determined specification/requirement. ”

All aspects of pharmaceutical manufacture require validation.

Sufficiently important to be referred to throughout the guidelines. eg. WHO 1 appendix 6

Normally states the requirement (not negotiable) but rarely “how to”



TRAININGWHO 1.10 and EEC 2.8 to 2.12

Detail training requirements

• General company culture

• On the job

• Outside courses

• Tests for proficiency

• Authorisation

• Training records



RECORDSFound in the documentation chapters of

the guidelines.

Examples

• Analytical test records

• Batch manufacturing documents (BMR)

• Cleaning records



CLEANLINESS AND HYGIENE

Fleeting reference in EEC and WHO

Guidelines

PIC gives better information #



QUALITYQuality Assurance

Both OG and WHO describe in detail the

elements of a robust quality system.

Emphasises its all embracing function



QUALITYQuality Control

Quality control of raw materials

Components

Intermediates and finished products.

Microbiology



QUALITYQuality Control

WHO 1.17 EEC 12.6

Quality control of raw materials

Components

Intermediates and finished products.

Microbiology

$ #



AUDITING FOR COMPLIANCE

WHO 1.8

EEC2.9

Describes the procedures

Aspects of pharmaceutical production to be

assessed.

Includes audits of suppliers.



Basic Principles of GMPBasic Principles of GMP

So what else is there?

ISO9000GAMP

??????

HTM 2010 Validation

of Autoclaves

BS 6001


OTHERS

ISPE Publications on good

Pharma Practice

HTM 2010 Validation of

Autoclaves



WHAT ELSE IS THERE Contract manufacture.

Technical agreements.

WHO 1.7

EEC 2.7

Both define contract giver and acceptor

And their individual and shared

responsibilities



WHAT ELSE IS THERE Complaints

Recalls

Returns

Stability programmes.



All the guidelines presented are objectives which

are not negotiable

Nowhere does it say if it costs too much one can

ignore the guideline

Nowhere does it say if the resources are

unavailable the guideline can be ignored.

Whist not negotiable, the means /ways of

achieving the objectives are a matter of company

style” one man’s solution is another man’s

disaster.


good practices in production and quality control. related guidelines john startup

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