List of cleaning validation guideline

This presentation consist a consolidated list all Regulatory Guidelines for Cleaning Validation. Hyperlink of the applicable guidelines are also given in the presentation.

1. List of Cleaning Validation Guidelines

2. 2 Hello! I am Avishek Sen Sarma You can find me at [email protected]

3. Agency Name : U.S Food & Drug Asminstartion Summary : Equipment and utensils shall be cleaned, maintained, and, as appropriate for the nature of the drug, sanitized and/or sterilized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements . No Residue limit or specific acceptance criteria is mentioned. TOC is accepted as an acceptable method for monitoring residues  Guidelines Reference : 211.67 Equipment cleaning and maintenance ( April-19) Validation of Cleaning Processes (Aug-2014) Questions and Answers on Current Good Manufacturing Practices—Equipment(July 2019) 3

4. Agency Name : European Medicines Agency (EMA) Summary : R eview and evaluate pharmacological and toxicological data of individual active substances and thus enable determination of threshold levels as referred to in the GMP guideline. These levels can be used as a risk identification tool and can also be used to justify carry over limits used in cleaning validation . Calculation of PDE value form NAOEL No guidance how to calculate cleaning limit. Guidelines Reference : Guideline on setting health based exposure limits (June 2015) Questions and answers on Guideline on setting health based exposure limits (April-2018) 4

5. Agency Name : Active Pharmaceutical Ingredients Committee (APIC) Summary : The criteria of Acceptable Daily Exposure (ADE) or Permitted Daily Exposure (PDE) are recommended to be used by companies to decide if Dedicated Facilities are required or not and to define the Maximum Acceptable Carry Over (MACO) of API’s in particular, in Multipurpose Equipment . Applicable for Active Pharmaceutical Ingredients No guidance how to calculate cleaning limit . Inline with EMA & ISPE guideline Guidelines Reference : Guidance on Aspects of Cleaning Validation In Active Pharmaceutical Ingredient Plants (Sep 2016) 5

6. Agency Name : World Health Organization (WHO) Summary : The criteria of Acceptable Daily Exposure (ADE) or Permitted Daily Exposure (PDE) are recommended to be used by companies to decide if Dedicated Facilities are required or not and to define the Maximum Acceptable Carry Over (MACO) of API’s in particular, in Multipurpose Equipment . Accepts the worst case approach to select representative approach Working Draft released in May 2020- Points to consider on the different approaches – including HBEL– to establish carryover limits in 6 cleaning validation… Guidelines Reference : WHO good manufacturing practices for active pharmaceutical ingredients-Annex 2 (2010 ) HEBL Related working draft (Aug 2020) 6

7. Agency Name :  Pharmaceutical Inspection Co-operation Scheme (PIC/S ) Summary : During an inspection attention should be paid to the risk management of cross-contamination; however, the amount of time allocated will depend upon the hazard level of the molecules, the type and number of products handled, and the degree to which facilities are proven to be separated and dedicated. PIC guideline exactly inline of EMA guideline Guidelines Reference : Guideline on Setting Health Based Exposure Limits-PI 046-1 (July 2018) Cross-contamination in Shared Facilities PI-043-1(July 2018) Guide to Good Manufacturing Practice For Medicinal Products Part I-PI 009-14(July 2018) Inspection Of Health Based Exposure Limit (HBEL) Assessments-PI 052-1 (June 2020) 7

8. Agency Name :  Therapeutic Goods Administration (TGA) No separate Guideline for TGA TGA adopts PICs Cleaning Validation Guideline PE009-13 (PIC/S Guide to GMP) Guidelines Reference : TGA interpretation and expectations for demonstrating compliance(Sep-2020) Cleaning Validation Presentation-A regulatory perspective 8

9. Agency Name :  Health Canada (HC) Summary : Cleaning procedures for products and processes which are very similar do not need to be individually validated. This could be dependent on what is common, equipment and surface area, or an environment involving all product-contact equipment. Promotes Cleaning Validation by evaluation of worst case scenario. Clear instruction related to cleaning revalidation criteria. Guidelines Reference : Cleaning Validation Guidelines -GUIDE-0028(January-2008) 9

10. Agency Name :  Parenteral Drug Association (PDA) Summary : PDA has published two separate documents related to Cleaning Validation. PDA Technical Report 29 for Actives and PDA Technical Report 49 for Biotechnology products. PDA Cleaning Validation Technical Reports are the most comprehensive guides when it comes to going into the depths of the Cleaning Validations and establishing a Cleaning Validation SOP for your firm. Guidelines Reference : PDA Technical Report 29: Points to Consider for Cleaning Validation (Dec 2012) PDA Technical Report 49: Points to Consider for Biotechnology Cleaning Validation  10

11. Agency Name :  International Society For Pharmaceutical Engineering (ISPE) Summary : ISPE also revised its Baseline Guide on Risk- MaPP (Risk-Based Manufacture of Pharmaceutical Products) and published in 2nd edition in 2017. The revisions are mostly in line with the 2015 EMA guideline on setting HBELs. Guidelines Reference : Baseline Guide Vol 7: Risk-Based Manufacture of Pharma Products 2nd Edition   Cleaning Validation Lifecycle - Applications, Methods, and Controls -Sep-2020 11

12. Agency Name :  American Society For Testing and Materials(ASTM) Summary : A unique thing about these standards is that it incorporates many of the science-based, risk-based, and statistical concepts and principles introduced in the FDA’s Guidance for Industry Process Validation. This guide supports and is consistent with, elements from ICH Q8, ICH Q9, ICH Q10, and ICH Q11 . Guidelines Reference : Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation-2018 -ASTM-E3106 Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)-2020 -ASTM E3219 12

13. 13 Thanks! Any questions? You can find me at [email protected]