Blogs about: Compliance Training
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USP method transfer
USP method transfer underwent a change when the US Pharmacopoeia published the final version of its informational chapter 1224, which deals with the transfer of analytical procedures mentioned in the… more →
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USP method transfer
wrote 2 weeks ago: USP method transfer underwent a change when the US Pharmacopoeia published the final version of its … more →
USP 1058 analytical instrument qualification
wrote 2 weeks ago: USP 1058 analytical instrument qualification is about ensuring that an instrument is suitable for it … more →
Sterilization
wrote 2 weeks ago: In lay terms, sterilization is understood in a number of ways. We have sterilization in economics, i … more →
Q7 guidelines
wrote 2 weeks ago: Q7 guidelines are those guidelines issued by the ICH (International Conference on Harmonization) in … more →
Method transfer FDA
wrote 2 weeks ago: A method transfer is the process of qualifying a laboratory regarding its ability to carry out an an … more →
Master Production Record (MPR)
wrote 2 weeks ago: A Master Production Record (MPR)is one of the several important documents that a manufacturer of fin … more →
ISO 13485 statistical techniques procedure
wrote 2 weeks ago: Being the global standard for quality management systems in medical devices; ISO 13485 has many cont … more →
ISO 13485 purchasing procedure
wrote 3 weeks ago: ISO 13485 has purchasing procedures for suppliers. ISO 13485 purchasing procedure is listed in Secti … more →
ISO 13485 design and development
wrote 3 weeks ago: ISO 13485 is the blueprint for quality management in medical devices. Design and development being v … more →
ISO 13485 customer property
wrote 3 weeks ago: ISO 13485 2003 is the global standard that concerns itself with quality management for medical devic … more →
ICH Q7 guidelines
wrote 3 weeks ago: What is ICH Q7? The ICH Q7 is a globally harmonized GMP guideline for Active Pharmaceutical Ingredie … more →
ICH guidelines for API
wrote 3 weeks ago: ICH guidelines for API are guidelines from the ICH specific to the active pharmaceutical ingredient … more →
ICH guideline Q7
wrote 3 weeks ago: As an ICH guideline, Q7 takes a primary position. ICH guideline Q7 relates to the whole range of Goo … more →
FDA guidance on method transfer
wrote 3 weeks ago: FDA guidance on method transfer is a kind of conundrum. On the one hand, there should be no complexi … more →
CMDR medical device classification
wrote 3 weeks ago: The Canadian Medical Device Regulations (CMDR) is the guidance that classifies medical devices in Ca … more →
CMDR classification
wrote 3 weeks ago: The Global Harmonization Task Force (GHTF) is deemed with the task of issuing guidance documents on … more →
BRC risk assessment
wrote 3 weeks ago: BRC, short for British Retail Consortium, is a body that sets global safety standards for food. Its … more →
BRC Risk Analysis
wrote 3 weeks ago: BRC risk analysis is about the guidelines issued by the international risk analysis body, the Britis … more →
Analytical method transfer
wrote 3 weeks ago: Analytical method transfer is an important element of a laboratory. A laboratory will be required to … more →
