Tag Archives: BERN

Investra-24hs USFDA warning Letter 12/28/17

February 25, 2018 USFDA WARNING LETTER Comments Off on Investra-24hs USFDA warning Letter 12/28/17 411

Investra-24hs USFDA warning Letter WARNING LETTER The United States (U.S.) Food and Drug Administration (FDA) recently reviewed your websites (listed at the bottom of this letter) and determined that they offer products for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More specifically, the websites listed …

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Code to Code Transfer of Materials and Additional Testing of Materials / Products

November 4, 2017 QA & QC, Quality Assurance Comments Off on Code to Code Transfer of Materials and Additional Testing of Materials / Products 2,550

Code to Code Transfer of Materials and Additional Testing of Materials / Products Objective (procedure) To lay down a procedure for code transfer of the same material from one code to another and to carry out additional testing of APIs, Excipients, and Drug Products to comply with other specifications or …

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CALIBRATION MASTER PLAN

September 20, 2017 QA & QC, Quality Assurance Comments Off on CALIBRATION MASTER PLAN 8,758

CALIBRATION Calibration is an essential procedure that involves the adjustment and validation of measurement instruments to guarantee their accuracy and consistency in providing dependable results. This practice holds immense significance across diverse sectors including manufacturing, healthcare, research, and others. In the absence of meticulous calibration, errors can permeate throughout operations, …

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SOP on In-process sampling of semi-finished product

September 16, 2017 QA & QC, Quality Assurance Comments Off on SOP on In-process sampling of semi-finished product 7,391

SOP on In-process sampling of semi-finished product Objective: To lay down the procedure for in-process sampling of semi finished drug product. Scope: This procedure is applicable to the in-process sampling of semi-finished drug product  in formulation plant of Pharmaceutical company. Responsibility: IPQA personnel are responsible for collecting in-process semi finished …

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SOP on execution of exhibit batches

September 14, 2017 QA & QC, Quality Assurance Comments Off on SOP on execution of exhibit batches 2,455

SOP on the execution of exhibit batches  Objective To lay down a procedure for the execution of exhibit batches. Scope This SOP is applicable for the execution of exhibit batches to the formulation plant of a Pharmaceutical company. Responsibility Officer/above of the production and quality assurance department shall be responsible. …

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SOP on withdrawal, storage, observation & destruction of control/retention sample

September 7, 2017 QA & QC, Quality Assurance Comments Off on SOP on withdrawal, storage, observation & destruction of control/retention sample 10,614

SOP on withdrawal, storage, observation & destruction of control/retention sample Objective: To lay down the procedure for withdrawal, storage, observation & destruction of control/retention sample from production (Oral & Injectable), Q.C. (RM Retention) . Scope: This SOP is applicable for the withdrawal, storage, observation & destruction of control samples from …

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