September 11, 2021: Pharmaceutical Interview Questions and Answers

#CleaningValidationGuidelines

1. What are the different guidelines/ regulations describing requirement of cleaning validation?

A. U.S. Food and Drug Administration (U.S. FDA)

PART 211 — CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS – Subpart D – Equipment

Source: Sec. 211.67 Equipment cleaning and maintenance.

Questions and Answers on Current Good Manufacturing Practices – Equipment

Source: https://www.fda.gov/drugs/guidances-drugs/questions-and-answers-current-good-manufacturing-practices-equipment

GUIDE TO INSPECTIONS VALIDATION OF CLEANING PROCESSES

Source: https://www.fda.gov/validation-cleaning-processes-793

B. European Medicines Agency (EMA)

20 November 2014, EMA/CHMP/ CVMP/ SWP/169430/2012, Committee for Medicinal Products for Human Use (CHMP), Committee for Medicinal Products for Veterinary Use (CVMP), Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Source: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-setting-health-based-exposure-limits-use-risk-identification-manufacture-different_en.pdf

19 April 2018 EMA/CHMP/CVMP/SWP/246844/2018 Committee for Medicinal Products for Veterinary Use (CVMP) Committee for Medicinal Products for Human Use (CHMP) Questions and answers on implementation of risk-based prevention of cross-contamination in production and ‘Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’ (EMA/CHMP/CVMP/SWP/169430/2012)

Source: https://www.ema.europa.eu/en/documents/other/questions-answers-implementation-risk-based-prevention-cross-contamination-production-guideline_en.pdf

C. World Health Organization (WHO)

QAS20 849 Points to consider on the different approaches –including HBEL – to establish carryover limits in cleaning validation for identification of contamination risks when manufacturing in shared facilities

Source: https://www.who.int/medicines/areas/quality_safety/quality_assurance/QAS20_849_points_to_consider_on_cleaning_validation.pdf?ua=1

WHO good manufacturing practices for active pharmaceutical ingredients 

Source: https://www.who.int/medicines/areas/quality_safety/quality_assurance/GMPActivePharmaceuticalIngredientsTRS957Annex2.pdf

Quality assurance of pharmaceuticals: A compendium of guidelines and related materials 

Source: https://www.who.int/medicines/areas/quality_safety/quality_assurance/QualityAssurancePharmVol2.pdf

Points to consider when including6 Health-Based Exposure Limits (HBELs) in cleaning validation 

Source: https://www.who.int/medicines/areas/quality_safety/quality_assurance/QAS20_849_Rev.1_points_to_consider_hbels_in_cleaning_validation.pdf?ua=1

D. Pharmaceutical Inspection Co-operation Scheme (PIC/S)

Cross-contamination in shared facilities (PI-043-1)

Source:  https://picscheme.org/docview/2270

Guideline on Setting HBEL for use in risk identification in the manufacture of different medicinal products in shared facilities (PI 046-1)

Source: https://picscheme.org/docview/2467

Guide to GMP for medicinal products Part 1 (PE 009-14 (Part I))

Source: https://picscheme.org/docview/4205

Inspection of Health Based Exposure Limit (HBEL) Assessment and use in Quality Risk Management (PI 052-1)

Source: https://picscheme.org/docview/1947

E. Therapeutic Goods Administration (TGA)

The TGA is adopting version PE009-13 of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PIC/S Guide to GMP)

Source: https://www.tga.gov.au/sites/default/files/transition-new-gmp-requirements-medicinal-products.pdf

TGA interpretation and expectations for demonstrating compliance 

Source: https://www.tga.gov.au/resource/pe009-pics-guide-gmp-medicinal-products

A presentation on Cleaning Validation by TGA

Source: https://www.tga.gov.au/sites/default/files/presentation-cleaning-validation.pdf

F. Health Canada

Cleaning validation guide (GUI-0028)

Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/validation/cleaning-validation-guidelines-guide-0028.html

G. Active Pharmaceutical Ingredients Committee (APIC)

Guidance on aspects of Cleaning Validation in Active Pharmaceutical Ingredient Plants APIC Cleaning Validation 2016

Source: https://apic.cefic.org/pub/APICCleaningValidationGuide-updateSeptember2016-final.pdf

Guidance on aspects of Cleaning Validation in Active Pharmaceutical Ingredient Plants APIC Cleaning Validation 2021

Source: https://apic.cefic.org/publications/APIC_Cleaning-validation-guide_2021.pdf

H. Parenteral Drug Association (PDA)

PDA Technical Report 29: Points to Consider for Cleaning Validation

PDA Technical Report 49: Points to Consider for Biotechnology Cleaning Validation

I. International Society For Pharmaceutical Engineering (ISPE)

Baseline Guide Vol 7: Risk-Based Manufacture of Pharma Products 2nd Edition ISPE Risk-MaPP

Cleaning Validation Lifecycle – Applications, Methods, and Controls ISPE Cleaning Validation Guideline

J. American Society For Testing and Materials (ASTM)

ASTM E3106 – 18e1 (Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation)

Standard Guide for Derivation of Health-Based Exposure Limits (HBELs) ASTM E3219

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