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

Sunday, May 22, 2011

LIMIT FOR RESIDUE AFTER CLEANING

Residue limit after equipment cleaning
US FDA have not mentioned specification or limits or methods cleaning and for residue after cleaning of equipments and its parts, as there are lot of variations in equipment designs and drug products to determine if the cleaning process is validated or not. Establishing the limit for residue after cleaning of equipments should be logical, it should be practical and achievable based on knowledge of chemistry of residue and it should be verifiable.

Some pharmaceutical industry representatives do mention  limits for residue after cleaning of equipments as 10 PPM for analytical detection level and for biological activity level as 1/1000 of the normal therapeutic dose of the drug in the residue, and organoleptic limit as no visible residues after cleaning. The residue of the detergent used must be absent or to a very low level only detectable in minute quantity in ultra low detection methods 

The sensitivity of the method used for detection and estimation of residue after cleaning should be capable to achieve the detection determinations and estimation of residues to the set limits level.

The drug residues may be from intermediates and byproducts may skip the regular method of detection hence complete screening of intermediates of drug products must be done, while setting up the limits.
TLC screening of the residue sample do provide good method for finding out the residue after cleaning, it is of great importance in case of steroidal drug products where very micro level of steroidal drugs contamination should be avoided. FDA guidelines

Cleaning Validation Protocol

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

Cleaning validation requirments

Cleaning validation evaluation and general requirements

Cleaning Validation and sampling procedures

Cleaning validation and equipment design.

 Types of validation in pharma validation .

Pharma sales jobs Find best pharma company 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