1.0 OBJECTIVE : To lay down a procedure for investigating and handling of Out of Calibration (OOC) of measuring device/Instruments. 2.0 SCOPE : This SOP is applicable to Out of Calibration of measuring device or instruments which are used for testing of Raw material, Packaging material, Finished Product and Stability samples in Quality Control Department. … Continue reading Handling of Out of Calibration in Laboratory
Temperature Mapping in Pharmaceuticals
1.0 OBJECTIVE : To describe a procedure for Temperature Mapping. 2.0 SCOPE : This SOP is applicable for the temperature mapping of storage, testing/incubation, chamber or any closed area. 3.0 RESPONSIBILITY : Concerned Departmental Head Quality Assurance Head 4.0 ACCOUNTABILITY: Quality Assurance Head 5.0 PROCEDURE : 5.1 A validation activity that centers on temperature and for relative … Continue reading Temperature Mapping in Pharmaceuticals
Handling of Laboratory Incidents
1.0 OBJECTIVE : This SOP defines the procedure for reporting, investigating and disposition of any incidents. 2.0 SCOPE : This SOP is applicable for investigating and detailing the sequence of events needed for handling of incidents occurred inadvertently in any department. 3.0 RESPONSIBILITY : It is the responsibility of respective department Officer / Executive to … Continue reading Handling of Laboratory Incidents
Quality Control in Pharmaceuticals Principle and General information
Quality Control Principle : Quality Control is concerned with sampling, specifications and testing as well as the organization, documentation and release procedures which ensure that the necessary and relevant tests are carried out, and that materials are not released for use, nor products released for sale or supply, until their quality has been judged satisfactory. Quality Control … Continue reading Quality Control in Pharmaceuticals Principle and General information
Deviation SOP and Production Interview Questions and Answers and Good Laboratory Practices (GLP)
Good Manufacturing Practices (GMP) Elements
Donation
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Amazon kindle Ebooks related to Pharmaceutical industry
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On Occasion of World Pharmacist Day
“I'm not a doctor; But patient care is my religion. A doctor's medicine saves two lives; But I fill my life with medicine by virtue of my knowledge and experience. Ability to read any doctor's prescription. Because I am a pharmacist, that is, a pharmacist. Indian philosophy says - Sarbe Bhabantu Sukhina, Sarbe Santu Niramaya... … Continue reading On Occasion of World Pharmacist Day
Drug Approval Process/Requirements for US, Europe and India
EMEA : European Medicines Evaluation Agency CHMP : Committee for Medicinal Products for Human Use TSE/BSE : Transmissible spongiform Encephalopathy/Bovine Spongiform Encephalopathy
Pharmaceutical Updates 