Quality Control

Out of Specification &Out of Trend Investigations (MHRA)

Out of Specification &Out of Trend Investigations (MHRA) Laboratory Analysis Investigations of “Out of Specification (OOS) / Out of Trend (OOT)/ Atypical results” have to be done in cases of: Batch release testing and testing of starting materials. In-Process Control testing: if data is used for batch calculations/decisions and if in a dossier and on …

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SOP ON OPERATION AND CALIBRATION OF pH METER (QC)

SOP ON OPERATION AND CALIBRATION OF pH METER   OBJECTIVE:  The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for Operation and Calibration of PH Meter. Make:……, Model: …….  ID No: …… SCOPE: This SOP is applicable to PH Meter in the Quality Control Department at Pharmaceutical manufacturing facility.   RESPONSIBILITY:   …

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What is an Active Pharmaceutical Ingredient?

What is an Active Pharmaceutical Ingredient? “active pharmaceutical ingredient (API) Any substance or combination of substances used in a finished pharmaceutical product (FPP), intended to furnish pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological …

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GMP Requirements for Certificates of Analysis (CoA)

GMP Requirements for Certificates of Analysis (CoA) At times of outsourcing and globalisation, the significance of Certificates of Analysis (CoA) is growing. Ultimately, the user of such certificates has to rely on their accuracy and completeness. There are CoAs for excipients, APIs, packaging materials and finished products. A closer look at the guidelines shows that there are …

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General Safety Rules for  Quality Control Laboratory. 

General Safety Rules for  Quality Control Laboratory. General Safety Rules For Quality Control Laboratory. General and specific safety instructions reflecting identified risk, should be made available to each staff member and supplemented regularly as appropriate (e.g. with written material, poster displays, audiovisual material and occasional seminars). General rules for safe working in accordance with national …

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Quality Control Testing of Raw Materials, APIs, and Finished Products.

Quality Control Testing of Raw Materials, APIs, and Finished Products. The Quality Control Testing  of Raw Materials, APIs, and Finished Products sample should be tested in accordance with the work plan of the laboratory after completion of the preliminary procedures. If this is not feasible the reasons should be noted, e.g. in the analytical worksheet, …

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