GCLP COP E-Letters

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E-Letters

E-Letters are topic-specific, electronic newsletters published four times per year by ISPE's global Communities of Practice (COPs). The content for E-Letters is submitted by professionals working in the pharmaceutical industry and is a resource by which to share best practices, regulatory news, technical articles and innovative solutions to real world problems.

*COPs are now an ISPE Member-only benefit, therefore some E-Letter content can be accessed only if you are an ISPE Member. Join ISPE today to continue accessing all E-Letter content and other valuable resources that will assist you in being more effective at your job.


July 2012

Organism Resuscitation
The authors of an article call for a closer look at a requirement for organism resuscitation as part of good practices for pharmaceutical microbiology labs mentioned in a WHO Technical Report Series. More.

ISPE to Publish Guide on Quality Laboratory Facilities
The ISPE Good Practice Guide: Quality Laboratory Facilities, expected to be released in August, will provide a baseline for the design of pharmaceutical quality laboratories. More.

Volunteer Your Expertise – Be Part of the Good Control Laboratory Practices COP
The GCLP COP, which has more than 1,000 members addressing issues related to the impact of laboratory processes on pharmaceutical manufacturing, is seeking a Steering Committee Member ( 88 KB) and Website Task Team Member ( 88 KB).

April 2011

Biochemical Tests on Microbiological Cultures
It is essential that all microbiological tests are quality controlled to guarantee that the result is true and this will normally form part of GLPs and the laboratory's accreditation compliance. Further, Schedule L1 for Indian GLPs mentions that standard biochemical tests are to be performed on cultures to ensure viability. Read More ( 72 KB) .

Contract Validation
Pharmaceutical companies widely contract validation activities when internal resources do not exist and cannot be acquired. Contract validation is used by small companies who do not have the required expertise or big companies who do not wish to perform it in-house. Read More ( 31 KB) .

What the GCLP Community is Discussing Right Now
Content uniformity – retesting approach, and micro testing continue to be topics of discussion on the GCLP COP site. Become an active member of the GCLP by contributing your thoughts to these topics or starting your own discussion thread. Read More.


October 2010

Quality Risk Management – A Study
An article discusses the application of Quality Risk Management (QRM) in the laboratory setting, using a case study on spectrophotometers, one located in a process laboratory of an API unit and the other in the quality control laboratory of a microbiology department. Read more ( 73 KB) .

Handling of Product Complaints
Handling of complaints is an important part of Good Manufacturing Practice. Complaints could be received from customers, regulators or from within the organization. An article gives a basic overview of SOPs that every manufacturer should have describing the methodology to be followed for complaint investigation. Read more ( 123 KB) .

What the GCLP Community is Discussing Right Now
Re-qualification /re-validation when the manufacturer of HPLC column has changed and lead time for analysis of stability samples continue to be hot topics of discussion on the GCLP Community of Practice site. Read more.


April 2010

Basic Design Considerations for a Testing Laboratory
The Ministry of Health and Family Welfare of India, under the Drugs & Cosmetics Act, has issued “Good Laboratory Practices” requirements and made the compliance of GLP mandatory effective 1 November 2010 for all pharmaceutical companies. Close to the requirement of Indian law, WHO also has issued a draft guidance of GLP for all establishments engaged in the testing of pharmaceutical products. Read more ( 430 KB) .

Presentations from the ISPE Free Workshop in Mumbai Available for Viewing
The following presentations from the ISPE Free Workshop held in Mumbai for young pharma professionals in February have been posted on the GCLP COP site. Read more.

What the GCLP Community is Discussing Right Now
Spread sheet validation, document management, and cephalosporin and non-cephalosporin laboratories continue to be hot topics of discussion on the GCLP COP site. Read more.


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