Topic 1-GMP Overiew of Concept

Good Manufacturing Practice
Overview of concept
WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES HYDERABAD, 10-18 NOVEMBER 2003 By: Alireza Khadem
WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES HYDERABAD, 10-18 NOVEMBER 2003
WHO
SEARO
Objectives of the workshop

Ensure that NRA will be able to conduct adequate GMP inspections
All GMP inspectors supervising EPI vaccine manufacturers will improve their skills in conducting competent and efficient GMP inspections identify GMP experts that can participate/facilitate in international peer review audits or GMP training/follow up
Develop a plan to ease enforcement of GMP in all EPI vaccine manufacturers

training of QA managers in self inspection Follow up and monitoring of GMP audits findings
WHO
SEARO
Expected outcome at the end of the workshop

A workplan to ease enforcement of GMP in by the NRA A workplan to implement and improve GMP in all EPI vaccine manufacturers A short term and long term training development plan of GMP inspectors and QA managers Identify the best resources persons to participate in WHO GMP audits or GMP training
WHO
SEARO
Organization & method of work

10-18 November, 8.30 am -5.30 including coffee break and lunch Evaluation of knowledge before, during and after the workshop Lectures based on need assessment Mock audit in two facilities (15,16 Nov) Work plan at the end of the workshop Plenary and working group sessions
WHO
SEARO
Why GMP
Patients taking medicines have very little chance of detecting if anything is wrong If something is wrong it can be very dangerous The doctor, pharmacist and patient, all trust those who manufactured and packaged the product
WHO
SEARO
History of GMP
1930 Lubeck BCG Vaccine
251 vaccinated 72 deaths because of tuberculosis 135 developed clinical tuberculosis 44 survived
Thorough investigations following this incident, it become very probable that batches of the vaccine were contaminated with the so-called Kiel-strain
WHO
SEARO
History of GMP
1938 - Sulphanilamide, the elixir of death
358 poisonings 107 deaths 251 sick but survived
FDCA-1938
The "miracle drug" came into use. It was marketed as a pediatric elixir. It was a raspberry flavoured solution in a liquid industrial solvent, etheylene glycol. Generally an elixir is designated as an alcohol based product, but this particular formulation was of dietheylene glycol. Upon ingestion, ethylene glycol was metabolized to oxalic acid.
WHO
SEARO
History of GMP
1962- Thalidomide
thousands of babies were born without arms or legs

Reason
Drugs must be effective & safe
One enantiomer caused sedation which was the desired effect, while the other enantiomer caused devastating birth defects known as Phocomelia. Solution was to remove the undesired enantiomer by a validated purification process assured by Assay Validation. Again, GMP deficiency by not having adequate QA and QC programmes which could have answered assay validation. This led to guidelines on the development of New Stereoisomeric Drugs (1992) US FDA.
WHO
SEARO
History of GMP
1955 - Polio Vaccine (Cutter Labs, USA)
(Lambert, E.C., Medical Mistakes, Indiana University Press, 1978)
51 Children paralysed 10 Deaths Several possible reasons:
Batch release
Inconsistent viral inactivation process. Quick scale-up production without proper validation of inactivation step. Active live virus production process used heat inactivation step. For virus; scale-up of heat inactivation step may not have been sufficient.
WHO
SEARO
History of GMP
PIC-GMP EC-GMP FDA-cGMP FDA-Aseptic Processing FDA-GMP GMP Enforcement by German National Law
WH0-GMP
1968
1971
1978
1983
1985
1987
1989
WHO
SEARO
History of GMP
Revision to Annex 1 EC-GMP
WHO-Revised GMP WHO-GMP for Biological products PIC-Adapts GMP According to EC-GMP WHO-GMP for Sterile pharmaceuticals WHO-Guide for Inspection
WHO-Revised GMP
1992
1992
1992
1996
1997
2002
2003
WHO
SEARO
What is GMP?
WHO
SEARO
More Paper More Work More Cost More Headache
WHO
SEARO
Quality Management
Determines and implements the quality policy The basic elements are: an appropriate infrastructure or quality system encompassing the Procedures, Processes, and Resources the systematic actions necessary to ensure adequate confidence that a product (or service) will satisfy given requirements for Quality The totality of these actions is termed Quality Assurance
WHO
SEARO
Quality management is defined as the aspect of management function that determines and implements the quality policy. The quality policy is a statement by the top management of the company of its overall intentions and direction relating to quality, formally expressed as a corporate policy.
WHO
SEARO
Quality Management
Terminology may differ Quality System is said to be rarely used in drug manufacturing
The concepts of QA, GMP and Quality Control are interrelated aspects of Quality Management. They are described on the following slides in order to emphasize their relationship and their fundamental importance to the production and control of pharmaceutical products
WHO
SEARO
There are two basic elements of this aspect of the management function of a pharmaceutical company:
A working infrastructure = quality system. This includes:
Organizational structure Procedures Processes Resources
Systematic actions to bring the quality policy to life. The totality of these actions is termed quality assurance (QA).
WHO
SEARO
Quality Relationships
Quality Objective Quality Manual Sampling Specifications Testing Personnel Training Validation Self inspection
Quality Control
Management Aspect Quality system Quality Policy
GMP
Quality Assurance
Quality Management
WHO
SEARO
Principles of Quality Assurance

Wide-ranging concept
covers all matters that individually or collectively influence the quality of a product
Totality of the arrangements

to ensure that the drug is of the right quality for the intended use
Quality Assurance incorporates GMP

and also product design and development
WHO
SEARO
Principles of Quality Assurance

Inside an organization, QA is a management tool. In contractual situations, it provides confidence in the supplier.
QA is not the duty of one organizational unit in the company alone, but is the responsibility of all staff members who in any way can influence product quality.
WHO
SEARO
Requirements for QA Systems I 1. 2. 3. 4. Ensure products are developed correctly Identify managerial responsibilities Provide SOPs for production and control Organize supply and use of correct starting materials 5. Define controls for all stages of manufacture and packaging
WHO
SEARO
Requirements for QA Systems II
6. Ensure finished product correctly processed and checked before release 7. Ensure products are released after review by authorized person 8. Provide storage and distribution 9. Organize self-inspection
WHO
SEARO
GMP
Ensure that products are consistently produced and controlled Diminishes risks that cannot be controlled by testing of product
Cross-contamination Mix-ups
WHO
SEARO
What is Good Manufacturing Practices (GMP)?
World Health Organization defines GMP as:
that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization
WHO
SEARO
Quality Standards
DRA
WHO GMP National GMP
NRA
NCL
Pharmacopeias
Inspection
Marketing Authorization
WHO
SEARO
Basic Requirements for GMP I

1. 2. 3. 4. 5. Clearly defined and systematically reviewed processes Critical steps validated Appropriate resources: personnel, buildings, equipment, materials Clearly written procedures Trained operators
WHO
SEARO
Basic Requirements for GMP II

6. 7. 8. 9. Complete records, failure investigations Proper storage and distribution Recall system Complaint handling
WHO
SEARO
What aspects of manufacturing does GMP cover?
Equipments
Complaints and Recalls Contract production and analysis Defined Processes
Materials and Storage Written Procedures and Records
Laboratories and Validated Tests
Premises
Validated Processes
Trained Personnel and Hygiene
WHO
SEARO
Quality Control (QC) Department
Each holder of a manufacturing authorization should have a QC Department Independence from production and other departments is considered to be fundamental Under the authority of an appropriately qualified and experienced person with one or several control laboratories at his or her disposal.
WHO
SEARO
Basic Requirements for Quality Control
Resources
Adequate facilities Trained personnel Approved procedures
WHO
SEARO
Basic Requirements for Quality Control
Tasks
Sampling Inspecting Testing Monitoring Releasing/rejecting
WHO
SEARO
Basic Requirements for Quality Control - I
Objects
Starting materials Packaging materials Intermediates Bulk products Finished products Environmental conditions
WHO
SEARO
Basic Requirements for Quality Control II

1. 2. 3. 4. Sampling approved by QC department Validated test methods Records Review and evaluation of production documentation 5. Failure investigations for all deviations 6. Ingredients comply with the marketing authorization
WHO
SEARO
Basic Requirements for Quality Control III 7. 8. 9. 10. Ingredients are of the required purity Proper containers Correct labelling Release of batches by the authorized person 11. Retained samples of starting materials and products
WHO
SEARO
Other Duties of the Quality Control Department

1. 2. 3. 4. 5. 6. Establish QC procedures Reference standards Correct labelling Stability testing Complaint investigations Environmental monitoring
WHO
SEARO
Assessment of Finished Products

Should embrace all relevant factors. For example: production conditions in-process test results manufacturing documentation compliance with finished product specification examination of the finished pack
WHO
SEARO
Other Issues
GLP GEP GCP GSP GDP
WHO
SEARO
Case study
List the most important barriers or Inhibitors against to Implement GMP
WHO
SEARO

Topic 1-GMP Overiew of Concept

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Good Manufacturing Practice

Objectives of the workshop

Develop a plan to ease enforcement of GMP in all EPI vaccine manufacturers

Expected outcome at the end of the workshop

Organization & method of work

358 poisonings 107 deaths 251 sick but survived

thousands of babies were born without arms or legs

51 Children paralysed 10 Deaths Several possible reasons:

More Paper More Work More Cost More Headache

Management Aspect Quality system Quality Policy

Principles of Quality Assurance

Totality of the arrangements

Quality Assurance incorporates GMP

Principles of Quality Assurance

Requirements for QA Systems II

What is Good Manufacturing Practices (GMP)?

World Health Organization defines GMP as:

WHO GMP National GMP

Basic Requirements for GMP I

Basic Requirements for GMP II

What aspects of manufacturing does GMP cover?

Complaints and Recalls Contract production and analysis Defined Processes

Materials and Storage Written Procedures and Records

Laboratories and Validated Tests

Trained Personnel and Hygiene

Quality Control (QC) Department

Basic Requirements for Quality Control

Basic Requirements for Quality Control

Basic Requirements for Quality Control - I

Basic Requirements for Quality Control II

Other Duties of the Quality Control Department

Assessment of Finished Products

List the most important barriers or Inhibitors against to Implement GMP

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