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Laboratory Investigation Checklist – OOS Result

Checklist / Check points of Laboratory preliminary Investigation (OOS Phase I) for find out the root cause for out of… Read More

Out of Specification (OOS) Handling Procedure

Guideline for Handling of Out of Specification (OOS) results occurs during analysis of Raw Material and Pharmaceutical Drug Products (Different… Read More

Vendor Assessment / Evaluation Checklist

Checklist for Assessment or Evaluation of Raw material vendor (manufacturer of supplier). The Successful evaluation of Vendor’s ability and capability… Read More

Vendor Audit & Qualification Management Procedure

Vendor Audit is an evaluation of vendor's manufacturing site, for product of interest(s), for the understanding and application of the… Read More

Stability Chamber / Incubator Management Procedure

Standard Operating Procedure (SOP) for Management of Walk in and stand-alone Stability Chamber used for Stability Study and also to… Read More

Cleaning Validation : Procedure & Protocol

Standard operating Procedure & Protocol for Cleaning Validation to prove that the equipment cleaning procedure can repeatedly and reproducibly remove… Read More

Method Verification (Analytical) Procedure (USP1226)

Standard Operating Procedure for performing analytical method verification of compendial procedure/ validated analytical methods in quality control department. Describes characteristics… Read More

Laboratory Safety – Procedure and Guidance

Standard Operating Procedure (SOP) and Guideline for Laboratory Safety, Handling of Laboratory incidents, Volatile materials, Corrosive Chemicals, Laboratory Glassware, Environmental… Read More

Laboratory Glassware Cleaning of Procedure

Standard Operating Procedure (SOP) for Cleaning of Laboratory Glassware. Occasionally, more aggressive cleaning solutions may be necessary when laboratory glassware… Read More

Viscometer – Operation and Calibration Procedure

Standard Operating Procedure (SOP) for Operation and Calibration of Brookfield make Viscometer used to determine the viscosity of solution /… Read More