Technology transfer/product transfer is a complete documented process that covers the detailed documentation for manufacturing and dispatch of the first batch, received from the parent location or FDD of a new or existing product from a particular site with manufacturing, packaging and analytical details. SOP on Technology Transfer of Drug Product 1.0 PURPOSE: […]
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Standard Operating Procedure (SOP) for Operation, Calibration, Cleaning, and Maintenance of FTIR (Fourier Transform Infrared Spectrometer). Procedure for Operation and Calibration of FTIR 1.0 PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the start-up, operation, calibration, and maintenance procedure of the FTIR – Fourier Transform Infrared Spectrophotometer. 2.0 SCOPE: This SOP
Standard Operating Procedure (SOP) for sampling from different points and microbiological analysis/testing of Purified water samples in pharmaceutical plants. Sampling and Testing of Purified Water in Microbiology 1.0 PURPOSE: To lay down the procedure for Sampling and Testing of Purified Water. 2.0 SCOPE: This Standard Operating Procedure is applicable to the Microbiology Department. 3.0 REFERENCE:
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Standard Operating Procedure (SOP) for Handling Power Failure situations in different areas like Production, Quality Control, 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 failure
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Standard Operating Procedure (SOP) for Physical and Logical Control Policy of Computer system to fulfill the requirement of 21CFR Part 11 under the cGMP activity in the pharmaceutical drug manufacturing unit. Computer System Control Policy1.0 Purpose: To define the process of the physical and logical security policy of the computer system.2.0 Scope: This applies to
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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 Release1.0 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 all
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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
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A Complete Guide on HPLC Calibration – Part 3 (Continued…) In the HPLC Calibration – A complete guide article series, we have discussed about Monthly & Quarterly Calibration parameters, rest of the parameters are described below, in the end of the article all the relevant links has mentioned, in this article there are total 3
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Continued from …. HPLC Calibration- A Complete Guide Part 1 Part 2 – HPLC Calibration on different Parameter starts from Energy check and completed on wavelength accuracy of Detector In the previous article on HPLC Calibration we have covered following parameters. Pressure Test. Drift and Noise Column oven and sample cooler Pump by flow rate
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Calibration of an instrument is the demonstration that the instrument or device produces results within specified limits by comparison with those produced by reference or traceable standard over an appropriate range of measurement. HPLC Calibration is the most critical activity in the laboratory, HPLC is the most sophisticated instrument in the Pharmaceutical Laboratory. This article
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