Professional Documents
Culture Documents
Tony Gould
Why GMP?
Provides a high level assurance that medicines are manufactured in a way that ensures their safety, efficacy and quality Medicines are manufactured to comply with their marketing authorization Quality is built in
Testing is part of GMP, but alone does not provide a good level of quality assurance
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Why inspect?
Verify compliance with GMP
Verify compliance with marketing authorization
Dossier: "Dedicated equipment is used" Inspection: Observation that this means "dedicated while used for the product or not being used for another product" Dossier: "The vials are removed from the lyophilliser and crimped in a grade A environment" Inspection: Correct, but before crimping they are stored in an uncontrolled corridor
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WHO GMP
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WHO good manufacturing practices for active pharmaceutical ingredients - Annex 2, WHO Technical Report Series 957, 2010 (Based on ICH
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Q7)
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Pharmaceutical excipients Sterile pharmaceutical products Biological products Pharmaceutical products containing hazardous substances Investigational pharmaceutical products for clinical trials i Herbal medicinal products Radiopharmaceutical products Water for pharmaceutical use HVAC for non-sterile pharmaceutical dosage forms Validation
PQ Workshop, Abu Dhabi | October 2010
9. Personnel
General
Key personnel
10. Training
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13. Equipment
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Quality Assurance
GMP
Section 1 and 2
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Quality Management
The basic elements are:
An appropriate infrastructure or quality system encompassing the organization structure, 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 referred to as Quality Assurance
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Procedures
Processes defined and recorded
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Quality Assurance
Quality assurance is a management tool
In contractual situations, it also serves to generate confidence in a supplier 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 1.1 pharmaceutical products
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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 continuously of the right quality for the intended use
Quality Assurance incorporates GMP and also includes product design and development, with special focus on process design
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1.1
QA
Production
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QC lab
Other Depts
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1.1 e - h
Regular evaluation of product quality to 1.1 i - l verify consistency and continued improvement
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(cont'd)
2.1 d - j
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Complaints handling
Complaints: Principle
All complaints and other information concerning potentially defective products must be carefully reviewed according to written procedures and corrective action should be taken.
5.1
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Complaints Procedure
Designated responsible person: To handle complaint Decide on measure to be taken May be authorized person - if not, must advise authorized person of results Sufficient support staff Access to records Written procedure (SOP): Describes action to be taken Includes need to consider a recall (e.g. possible product defect) 5.2 5.3
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5.7 5.9
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Self-Inspection
Purpose is to evaluate whether a companys operations remain compliant with GMP The programme should
cover all aspects of production and quality control be designed to detect shortcomings in the implementation of GMP recommend corrective actions set a timetable for corrective action to be completed
8.1
Self-Inspection (cont'd)
Performed by team appointed by management, with: authority sufficient experience, expertise in their own field. knowledge of GMP may be from inside or outside the company Frequency should normally be at least once a year May depend on company requirements Size of the company and activities
8.3, 8.4
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Self-Inspection (cont'd)
Report prepared at completion of inspection, including:
results evaluation conclusions recommended corrective measures
Follow-up action
Effective follow-up programme Company management to evaluate both the report and corrective actions
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8.5, 8.6
http://www.who.int/prequal
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