Month: December 2018

FAILURE (OUT-OF-SPECIFICATION) OOS LABORATORY RESULTS (USFDA)

FAILURE (OUT-OF-SPECIFICATION) OOS LABORATORY RESULTS (USFDA) Evaluate the company’s system to investigate laboratory test failures (OOS). These investigations represent a key issue in deciding whether a product may be released or rejected and form the basis for retesting, and resampling. In a recent court decision the judge used the term “out-of-specification” (OOS) laboratory result rather …

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SOP on ENTRY, EXIT & GOWNING PROCEDURE IN MICROBIOLOGY TESTING AREA( Non- Sterile ).

SOP on ENTRY, EXIT & GOWNING PROCEDURE IN MICROBIOLOGY TESTING AREA( Non- Sterile ). OBJECTIVE :- The objective of this SOP is to give exact idea about the procedure for entry exit & gowning in Microbiology testing area. SCOPE:- This SOP is applicable for the entry exit & gowning in microbiology testing area. RESPONSIBILITY:- Microbiologist, Lab Assistant …

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What are the responsibilities of a quality control?

What are the responsibilities of a Quality Control?( As per EudraLex Vol-4 & USFDA) Control laboratory premises and equipment should meet the general and specific requirements for Quality Control areas given in Chapter 3. Laboratory equipment should not be routinely moved between high risk areas to avoid accidental cross-contamination. In particular, the microbiological laboratory should …

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What are the Job Responsibilities of Quality Control Head & Quality Unit Joint Responsibilities.

Job responsibilities of The head of Quality Control & Joint Responsibility of The heads of Production, Quality Control,Head of Quality Assurance or Head of Quality Unit To approve or reject, as he sees fit, starting materials, packaging materials, intermediate, bulk and finished products; To ensure that all necessary testing is carried out and the associated records …

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