This website is written by experts in Pharmaceutical Industry Manufacturing Research and Development and Regulatory Affairs Since 2008 and in 2011 Awarded as one of top 10 websites across world in Pharmaceutical Manufacturing Regulatory
USFDA WHO GMP Guidelines Pharmaceutical Regulations Information about Pharma Quality Managment System Validations Process Validation Cleaning Validation Equipment Qualification Equipment Process Validation Computer System Validation Sterile Product Manufacturing Guidelines Media fill guideline Aseptic Techniques in Sterile dosage form Clean Room Clean Room Classification Guidelines on Area Qualification HVAC AHU HEPA Filter HEPA Filter integrity testing and leak test

Tuesday, May 31, 2011

Cleaning Validation and sampling procedures

Sampling in cleaning validation:
Direct sampling (swab test) .
There are two sampling methods which are most used and are accepted by regulatory agencies world wide , they are direct sampling methods that is the sampling of surface of the equipment and rinse solutions .
The advantages of direct sampling method in cleaning validation is that the surfaces of equipments and machines which are otherwise difficult for cleaning can be evaluated for their cleanness after cleaning.
The effectiveness of this method should be evaluated properly the sampling adhesives in swab many time have tendency to interfere with the test, therefore in while making the validation program and cleaning validation protocol the materials used for sampling should be verified for their interference. The residues which get dried or are insoluble can be directly sampled by physical means.

Rinse water (Rinse solution sampling, rinse water analysis).
The advantage rinse sampling is that the large aria of the surface of equipment can be sampled and evaluated. The areas which are otherwise not accessible for direct sampling can be washed with the rinse solution and the rinse sample can be analyzed for the residue after cleaning. Rinse water, rinse solution sample can be taken over from the parts of equipments which can not be disassembled.
Alternative method for sampling should be adapted when the residue becomes insoluble and occlude the equipment, observing the equipment by a quality assurance personal physical is of importance in such cases.
Only rinse water quality test for contamination is not acceptable by regulatory agencies rather they want the evaluation whether it meets the required limits and whether it can assure that the cleanness of equipment when it is used during cleaning validation, it should be able to test it for potential contaminates.

The quality assurance procedures should be in place for direct or physical observation of residues after cleaning.
good manufacturing practices
Cleaning validation series:

Cleaning Validation Protocol

Residue of detergent after equipment cleaning, is there any limit for residue of detergent ?

LIMIT FOR RESIDUE AFTER CLEANING

Cleaning validation requirements

Sterile drug product validations
Aspects of Validation of Aseptic Process and Sterilisation , Sterilization of Equipment, Containers, and Closures

What is pharmaceutical product information manual (Pharmaceutical product dossier) for registration of pharmaceutical product to foreign countries

--------------------------------------------------------------------------------------------------------

Pharmaceutical Process Validation Series

Process Validation documentation.

Pharma process validation and concurrent release of PPQ batches

Process validation aspects of Analytical Methodology.

Process Validation Stage 3 The Continued Process Verification.

Process Validation : Process Qualification and Process Performance Qualification (PPQ)

Process Design and Process Validation Recommendations

Process validation and its regulatory, statutory requirements.


Process Validation and Drug Quality Approach to Process Validation.


General Considerations for Process Validation and Recommendations


Terms used in pharma validations and their definitions

Quality by design concept for pharmaceutical industry

Quality by design concept in pharmaceutical industry an explanation


Clean Room Classification

Pharma sales jobs Find best pharmaceutical sales Job

No comments:

Pharma Guidelines Most Read

.

Readers Visit Number

This website is Authentic Source of Pharmaceutical Guidelines

This website is Authentic Source of Pharmaceutical Guidelines

Pharma Validations Quality Management System USFDA Guidelines WHO GMP Guidelines New Drug Update





This website consist of detail Information about Pharma Guidelines Pharma Regulatory Affairs USFDA Guidelines WHO Guidelines Pharmaceutical Quality Management System Pharma Validations Process Validation Cleaning Validation Equipment Qualification Equipment Process Validation Computer System Validation Sterile Product Manufacturing Guidelines Media fill guideline Aseptic Techniques in Sterile dosage form Clean Room Clean Room Classification Guidelines on Area Qualification HVAC AHU HEPA Filter HEPA Filter integrity testing and leak test