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Wednesday, January 29, 2014

Cleaning Validation Pharma


Cleaning Validation Pharma:

What is validation ?: Validation is an activity in pharma company which is undertaken to generate documentary evidence to establish  that a process or procedure or a method methodology adapted in pharmaceutical manufacturing process, its procedures like, cleaning and testing of pharmaceutical product yields desired and predetermined result.

For more information on pharmaceutical validation read this. 

http://whoguideline.blogspot.com/2010/03/validation-in-pharmaceutical.html

Cleaning procedure is very important activity in pharma manufacturing, Cleaning is done to prevent contamination from air borne dust, dirt and residue of active pharmaceutical ingredient or excipients from other products and residues of detergent and disinfectant , microbial contaminants, so as to protect product to be manufactured will be free from from cross contamination from such contaminants, there are some drugs which have very potent activity even in very low amount and dose such products when contaminated with product being manufactured can lead to very serious hazards.

Pharma Cleaning Validation:
It is a process of generating , gathering data which establish that cleaning activity carried out is satisfactory , and is able to remove all sorts of contamination, residues to a predetermined and acceptable level, from actual cleaning activity carried out under supervision of qualified technical staff as per the established standard operating procedure and as per the validation master plan, the residue may be airborne particulate matter, microbe, or residue of active pharmaceutical product or residue of disinfectant and detergent used for cleaning.


Objective of the procedure should be to establish documentary evidence that the procedure adapted in cleaning is able to provide desired level of cleaning consistently.

Limit of the residues of previous products is calculated by keeping in consideration its pharmacological activity, mode of action, and LD 50 , batch size ect. This is also called as

The Cleaning validation is performed to demonstrate the effectiveness of procedures for Cleaning to remove residue of previous product.

A standard operating procedure is made in consideration of all aspects of batch size, contaminants, and residues remaining after cleaning.

A Validation master plan is drafted to plan all activities in cleaning validation as sequentially done in proper order, beginning from identification of aira, machinery and sampling procedure and testing for residue. Based on this a cleaning validation protocol is prepared and followed during validation process.

This include details as cleaning procedure, sampling procedure and sample quantity ,
Specification with limits for residue and test procedures.

Maximum carry over limit of drug reside after cleaning depends up on the various factors like LD50, therapeutic index of the drug in question, there are many other factors which must be considered, factors related to previous product are alergenic capabilities , minimum therapeutic does , daily dose limit. Equipment factors which are also required to be considered are equipments series used to manufacture the previous product which will be again be used for nex product, minimum batch size of the next product where in the left over residue might get mixed and diluted, and never the less the amount of solvent used to take swab samples for the purpose of calculation, and surface aria of the equipment cleaned.

Other important factors like teratogenesity and allergenic capabilities of drug molecule or its metabolites are also required to be considered in assigning maximum carry over limit after a cleaning procedure in pharmaceutical manufacturing process.

Microbial limits : The cleaning procedure adapted must be able to remove all pathogenic microorganisms, and allow to maintain the lowest possible load that is almost lower than the limits for raw as well active ingredients of a pharmaceutical product being manufactured.

Revalidation in pharmaceutical processes
CLEANING VALIDATION PROTOCOL

Cleaning validation general requirements

Cleaning Validation and sampling procedures

Cleaning Validation and Analytical methods used for detection of residue 

Cleaning validation and equipment design.

Test for Total Organic Carbon (TOC) (TC ) for evaluation of efficacy of cleaning process:

Placebo batch for evaluation and validating efficacy of cleaning process: 


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