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A Review on Cleaning Validation-Regulatory Guidelines for The Pharmaceutical Industry
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Manufacturing of Pharmaceutical products shall demonstrate a control to reproduce consistently the desired quality of product, wherein the control of cross-contamination plays an important role. An effective cleaning shall be in place to provide documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels. Pharmaceutical manufacturers must validate their cleaning process to ensure compliance with cGMP regulations. So it is necessary to validate the cleaning procedures to ensure safety, efficacy, quality of the subsequent batches of drug product and regulatory requirements in Pharmaceutical product manufacture. In this article cleaning validation and cleaning validation program discussed in brief.
Keywords
- FDA expects firms to have written standard operating procedures (SOP) detailing the cleaning process used for various pieces of equipment.
- If firms have a specific cleaning process for cleaning between different batches of the same product and use a different process for cleaning between product changes, FDA expects the written procedures to address these different scenarios.
- Parenteral drug association, Points to consider for cleaning validation, technical report no. 29, 1998.
- Galatowitsch S; The importance of cleaning validation. Clean rooms; 2000
- Babita Lodhi, Poonam Padamwar, Arif Patel; Cleaning validation for the pharmaceuticals, biopharmaceuticals, cosmetic and neutraceuticals industries, Journal of Innovations in Pharmaceuticals and Biological Sciences; 2014; 1(1); 27 – 38.
- FDA, guide to inspections of validation of cleaning process division of investigations, office of regional operations and office regulatory affairs, 1993.
- European Medicine Agency. Guideline on Setting Health Based Exposure Limits for Use in Risk Identification in the Manufacture of Different Medicinal Products in Shared Facilities. London, UK: EMA; November 2014.
- Kumar S. A review on concept of cleaning validation in pharmaceutical Industry. International Research Journal of Pharmaceutical Sciences. 2012; 3(7): 17-19.
- Jenkins M; Cleaning validation; an overall perspective; Pharma tech, 1994; 18(4); 60-73.
- Hyde JM; Cleaning validation strategies, ISPE CIP/SIP seminar, Atlanta-Georgia, 1994
- Leblanc DA; Rinse sampling for cleaning validation studies; Pharma tech. 1998.
- PDA Technical Report No. 29, Revised 2012 (TR 29) Points to Consider for Cleaning Validation (single user digital version) of Publication: Dec 2012.
- ISPE: Volume 7 – Risk-Based Manufacture of Pharmaceutical Products (Second Edition). Published: August 2020 Pages: 236.
- Active pharmaceutical ingredients committee (apic) guidance on aspects of cleaning validation in active pharmaceutical ingredient plants revision September 2016
- ASTM International. "What is ASTM International?" The History of ASTM International. Retrieved 12 May 2021.
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