1.0       OBJECTIVE 1.1       To lay down a cleaning procedure for Multimill. 2.0       RESPONSIBILITY Technical Assistant – To follow the SOP. Executive – To comply the SOP. 3.0         PROCEDURE:   3.1     TYPE “A” CLEANING ( Batch to Batch Changeover): 3.1.1    Ensure that status label is updated as “TO BE CLEANED”. 3.1.2    Switch off the … Continue reading Cleaning Procedure for Multi mill →

1.0       OBJECTIVE To lay down a procedure for the operation of Multimill. 2.0       RESPONSIBILITY Technical Assistant – To follow the SOP. Executive – To comply the SOP. 3.0       PROCEDURE 3.1 Check the cleanliness of the area and the machine. 3.2    Use cleaned scoops during the milling operation. 3.3   Get line clearance from QA department before starting … Continue reading SOP for Multimill →

1.0       OBJECTIVE 1.1        To lay down a cleaning procedure for Vibratory Sifter 2.0       RESPONSIBILITY Technical Assistant – To follow the SOP & Cleaning of sifter.Executive – To verify the Cleaning of sifterExecutive – Responsible for compliance of SOP 3.0     PROCEDURE:    TYPE “A” CLEANING (Dry Cleaning/Batch to batch Cleaning):    Ensure that status label is updated as … Continue reading Cleaning procedure for Vibratory Sifter →

1.0       OBJECTIVE 1.1       To describe the procedure for operation of Vibratory Sifter. 2.0       RESPONSIBILITY Technical Assistant – To follow the SOP & operation of sifter.Executive – To verify the operation of sifterExecutive – Responsible for compliance of  SOP. 3.0 DEFINITION Vibratory Sifter is used in Sifting of materials in Pharmaceutical manufacturing with different mesh of … Continue reading SOP for Vibratory Sifter →

1.0Objective : To lay down the procedure for conducting Mock Recall.2.0Scope : Scope of this document is to follow procedure for Mock Recall.3.0Responsibility :3.1Quality Assurance Department for conducting, monitoring and administration of Mock Recall procedure.4.0Definition(s) of Mock Recall: Mock recalls are routine exercises conducted by manufacturers, processors, distributors and other various trading partners in the supply chain to … Continue reading Procedure for Handling of Mock Recall →

Objective : To lay down a Procedure for Trend Analysis.   Scope : The scope of this document is to provide the Procedure for Trend Analysis of but not limited to Water analysis results, Environmental monitoring results, in Quality Control Department.    Responsibility :      Quality Control Personnel  :       To prepare the trends of results.      To review … Continue reading Procedure for Trend Analysis →

Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue guidelines for drug development, licensing, registration, manufacturing, marketing and labeling of pharmaceutical products. So below are the list of Countries along with their Regulatory authority with Full Name

What is Control Sample: An appropriately identified sample that is representative of each batch that shall be retained is known as control sample. These are also referred as retention or reserve sample. Control samples shall be collected for Finished Product, Raw Material and Packing Materials. Why Control Sample shall be collected: As per regulatory and … Continue reading Control Sample Management in Pharmaceuticals →

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