Standard Operating Procedure (SOP) for Operation and Calibration of Friability Test Apparatus used to perform the analysis of the Friability Test in solid doses form (Tablet). Procedure For Operation and Calibration of Friabilator 1.0   Purpose: The purpose of this SOP is to describe the procedure for operation and calibration of the Friability apparatus. 2.0   Scope […]

Standard Operating Procedure (SOP) and Policy/Program for Calibration of Instrument, Equipment, and Measuring Device used to measurement, monitoring, and controlling of operation and process in different departments at the Pharmaceutical Drug Manufacturing Plant. Calibration is a set of operations that establish under specified conditions, the relationship between values indicated by a measuring instrument or measuring […]

Standard Operating Procedure (SOP) for Handling of Out of Specification (OOS) test results in packaging (packing) material so as to ensure that all such test results are properly investigated and closed before taking a decision to release/reject the item, and corrective actions are taken to avoid recurrence. Handling of Out of Specification (OOS) in Packaging […]

Standard Operating Procedure (SOP) for Process Standardization and Validation be carried for the new products and existing products at the formulation plant. SOP for Process Standardization and Validation 1.0   Purpose: To lay down a procedure for process standardization and process validation study. 2.0   Scope – Process Standardization and Validation: The SOP is applicable to process […]

Standard Operating Procedure (SOP) for approval and release of Finished Product Batch for moving from the manufacturing site to supply chain/distributors or C&F warehouses.  Procedure for Finished Product Batch Release 1.0   PURPOSE: To lay down the procedure for approval and release of the finished product batch. 2.0   SCOPE: This Standard Operating Procedure is applicable for […]

Standard Operating Procedure (SOP) for Cleaning Validation (CV) in the pharmaceutical drug manufacturing plants. Cleaning Validation (CV) is the documented evidence that an approved cleaning procedure is consistent in reducing product residue and removal of cleaning agents (if any), bioburden, flavor (if any), color (if any) from equipment and accessories within the acceptance level. Procedure […]

Standard Operating Procedure (SOP) for Handling Power Failure situations in different areas like Production, Quality Contro, Microbiology, Utility, Stores, etc at the pharmaceutical drug manufacturing plant. Procedure for Handling of Power Failure in Pharma 1.0   Purpose: To lay down a procedure for handling power failure situations. 2.0   Scope: This procedure is applicable to handling power […]

Standard Operating Procedure (SOP) for Media Fill Validation in Sterile facility.  A “media fill” (sometimes known as a “process simulation”) is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium in place of the drug solution. The microbiological growth medium is used in place of the drug solution during media fills […]

Chromatography is a laboratory technique for the separation of a mixture. The mixture is dissolved in a fluid called the mobile phase, which carries it through a structure holding another material called the stationary phase. The various constituents of the mixture travel at different speeds, causing them to separate. GOOD CHROMATOGRAPHY PRACTICES 1.0   PURPOSE : The […]

Protocol for Qualification and Re-Qualification or Validation of Heating Ventilation and Air Conditioning (HVAC) system for Clean Room. HVAC System Qualification Protocol (Validation) Table of Content – HVAC System Qualification Protocol    S.No. Table of Contents Page 1.0 Protocol Approval 2.0 History Sheet 3.0 Objective 4.0 Scope 5.0 Responsibilities 6.0 Equipment Description 6.1 System Specification […]

Standard Operating System (SOP) for Qualification and Re-Qualification of Heating Ventilation and Air Conditioning (HVAC) system for Clean Room. Qualification of HVAC System 1.0   PURPOSE The Purpose of this SOP is to lay down the Procedure for qualification/Requalification, of Heating Ventilation and Air Conditioning System (HVAC). 2.0   SCOPE This SOP is applicable for the qualification/requalification […]

Standard Operating Procedure (SOP) for the handling of Pharmacopoeial Change at Drug Product Manufacturing Location. Handling when Pharmacopoeial changes in monographs and appearance of the new monographs for drug substances, excipients, drug products and updation or addition or deletion of general chapters.  Handling of Pharmacopoeial Change at Drug Manufacturing Location 1.0   Purpose: To define the […]

Standard Operating Procedure (SOP) for Operation and Calibration of Dissolution Test Apparatus (Make- Electrolab) used to measure the drug release of Oral Solid Doses in pharmaceuticals. This SOP Contains following Topics – A) Operating Procedure for Electrolab Dissolution Apparatus, Model : TDT-08L 0, TDT-14L, and similar models. B) Calibration Procedure and Formats for Dissolution Apparatus […]

Standard Operating Procedure (SOP) for Operation and Calibration of Melting Point Apparatus used for analysis / identification  of starting materials (Raw Material – API & Excipient) in Quality Control Laboratory. Operation and Calibration of Melting Point Apparatus 1.0   PURPOSE: The purpose of this SOP is to describe the procedure for operation, calibration and maintenance of […]

Standard Operating Procedure (SOP) for operation and maintenance of Laboratory Oven used for glassware dying or Loss on Drying etc. in quality control laboratory. SOP for Laboratory Oven 1.0   PURPOSE: The purpose of this SOP is to describe the procedure for the operation and maintenance of a laboratory oven. 2.0   SCOPE: This SOP is applicable […]