Content area
Full Text
(ProQuest: ... denotes formulae omitted.)
INTRODUCTION, PRINCIPLE AND OBJECTIVE:
Cleaning Validation is the methodology used to assure that a cleaning process removes residues of the active pharmaceutical ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes. All residues are removed to predetermined levels to ensure the quality of the next product manufactured is not compromised by waste from the previous product.
Pharmaceutical products can be contaminated by a variety of substances such as contaminants associated with microbes, active pharmaceutical ingredients (API) and excipient residues of previous products, residues of cleaning agents, airborne materials such as dust and particulate matter, lubricants and ancillary material, such as disinfectants, and decomposition residues from:
· Product residue breakdown occasioned by. e.g. the use of strong acids and alkalis during the cleaning process and
· Breakdown products of the detergents, acids and alkalis that may be used as part of the cleaning process.
The objective of cleaning validation is to prove that the equipment is consistently cleaned of product, detergent and microbial residues to an acceptable level, to prevent possible contamination and cross-contamination.
Cleaning validation is documented evidence which provide high degree of assurance that an approved cleaning procedure will provide equipment that is suitable for processing of pharmaceutical products or API.
REGULATORY REQUIREMENTS FOR CLEANING VALIDATION:
The FDA (Food and Drug Administration) establishes the regulations and policies relating to pharmaceutical grade products distributed commercially in United States. These regulations are called current Good Manufacturing Practices (cGMP) and are classified in Title 21, part 211 of the Code of Federal Regulation (CFR). The applicable laws at this time are general and somewhat vague, and are centered around 21 CFR 211.67 that states: "Equipment and utensils be cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality or purity of the drug product". According to this law each and every pharmaceutical and food industry should follow the cleaning validation program to avoid malfunctioning, contamination and cross contamination of finished product.
CLEANING VALIDATION PROGRAM:
Equipment cleaning validation may be performed concurrently with actual production steps during process development and manufacturing. Validation program should be continued through full scale commercial...