GMP Inspection Process Types of GMP Inspection Module

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GMP Inspection Process Types of GMP Inspection Module 19 | Slide 1 of 14

GMP Inspection Process Types of GMP Inspection Module 19 | Slide 1 of 14 January 2006

Types of GMP Inspection Objectives 1. To review the different types of inspection 2.

Types of GMP Inspection Objectives 1. To review the different types of inspection 2. To examine when each is appropriate 3. To discuss inspections in your country Module 19 | Slide 2 of 14 January 2006

Types of GMP Inspection Objective of the inspection l Routine inspection l Concise inspection

Types of GMP Inspection Objective of the inspection l Routine inspection l Concise inspection l Follow-up inspection l Special inspection l Quality systems review Module 19 | Slide 3 of 14 January 2006

Types of GMP Inspection Routine Inspection l l Full inspection of all components of

Types of GMP Inspection Routine Inspection l l Full inspection of all components of GMP Newly established manufacturer Renewal of a license Changes: new product or product lines modifications to manufacturing methods key personnel, premises or equipment l History of non-compliance with GMP l Not inspected in the last 3 -5 years Module 19 | Slide 4 of 14 January 2006

Types of GMP Inspection Concise Inspection l Consistent record of compliance with GMP l

Types of GMP Inspection Concise Inspection l Consistent record of compliance with GMP l Focus on limited number of GMP requirements selected as indicators l Identify significant changes l Indicate attitude towards GMP l Non-compliance should trigger comprehensive inspection Module 19 | Slide 5 of 14 January 2006

Types of GMP Inspection Follow-up Inspection l Reassessment or re-inspection l Monitor result of

Types of GMP Inspection Follow-up Inspection l Reassessment or re-inspection l Monitor result of corrective actions l 6 weeks to 6 months after initial inspection nature of defects work undertaken l Specific GMP requirements not observed – not adequately implemented Module 19 | Slide 6 of 14 January 2006

Types of GMP Inspection Special Inspection l Spot check focusing on one product, a

Types of GMP Inspection Special Inspection l Spot check focusing on one product, a group of related products specific operations, e. g. mixing, labelling l Complaints or recalls l Adverse drug reactions l Marketing approval or export certificate l Information or investigation specific information advice on regulatory requirements Module 19 | Slide 7 of 14 January 2006

Types of GMP Inspection Quality Systems Review l l Assess the quality assurance (QA)

Types of GMP Inspection Quality Systems Review l l Assess the quality assurance (QA) system Description of the QA system (e. g. manual) Policy and standards to be observed Management structure implementation l Procedures quality standards set for products correctly defined manufacturing processes records kept QC and QA functions are performed Module 19 | Slide 8 of 14 January 2006

Types of GMP Inspection Frequency of Inspections l l Depends on type of inspection

Types of GMP Inspection Frequency of Inspections l l Depends on type of inspection Inspectorate resources (e. g. workload, number of inspectors) New facilities - before licensed All companies - regular schedule ideally annual l Large companies several visits over a period, e. g. 5 years validity of manufacturing license or GMP certificate Module 19 | Slide 9 of 14 January 2006

Types of GMP Inspection Duration of Inspections l Depends on type of inspection l

Types of GMP Inspection Duration of Inspections l Depends on type of inspection l Inspectorate resources (e. g. workload, number of inspectors) l Size of the company l Purpose of the visit l Days to weeks l Number of inspectors including specialist support Module 19 | Slide 10 of 14 January 2006

Types of GMP Inspection Announced and unannounced inspections l Depends on type of inspection

Types of GMP Inspection Announced and unannounced inspections l Depends on type of inspection l Announced comprehensive inspection l Unannounced routine inspection (depending on country policy) concise inspection follow-up inspection special inspection Module 19 | Slide 11 of 14 January 2006

Types of GMP Inspection Regulatory Actions l Based on national regulations l Correction of

Types of GMP Inspection Regulatory Actions l Based on national regulations l Correction of unsatisfactory situations l Closing down of a factory l Withholding of authorizations l Product recall Module 19 | Slide 12 of 14 January 2006

Types of GMP Inspection Group Session l The inspectorate received a complaint that an

Types of GMP Inspection Group Session l The inspectorate received a complaint that an injectable product (water for injection (WFI), 10 ml ampoule) is possibly contaminated with microorganisms. You have to organize an inspection of the company in question l What type of inspection would be performed? l Will the inspection be announced or unannounced? l Who will be part of the inspection team? l What will you consider in preparation for the inspection? Module 19 | Slide 13 of 14 January 2006

Types of GMP Inspection Possible Issues l Purpose of the inspection l Notification (or

Types of GMP Inspection Possible Issues l Purpose of the inspection l Notification (or not) of the company in advance l Make-up of the team l Programme for the inspection l Sterility test, leak test and visual inspection l Validation and qualification l Documentation review Module 19 | Slide 14 of 14 January 2006

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