This category includes Quality Assurance SOP’s.
Procedure for Isolation and Identification of Microbial Cultures & Microbial Isolates using different Analytical Methods from the manufacturing environment of OSD, oral liquid, sampling & Dispensing area, Microbiology section and water isolates from water system, colony isolated from MLT positive results and Standard Microbial cultures. Isolation and Identification of Microbial Cultures & Microbial Isolates 1.0 Objective : To lay down…
Standard Operating Procedure (SOP) for Failure Investigation (process failure as well as non-process failure) occurs during manufacturing or processing of drug products. Failure Investigation 1.0 Objective : To lay down the procedure for failure investigation of any activity to meet its predetermined specification, limits or acceptance criteria. 2.0 Scope : This SOP is applicable to process failure as well as…
This SOP describes the process and requirements for the transfer of analytical test method from an originating laboratory (Transferring Unit) to a receiving laboratory (Receiving Unit). This SOP provides the requirements for the transfer of validated analytical methods. It defines a process for preparing for transfer, executing transfer testing and preparing final reports. Analytical Method Transfer 1.0 PURPOSE: This SOP…
Standard Operating Procedure for Microbiological Analysis of Water used for manufacturing of various drug product in pharmaceutical industry. Procedure for Microbiological Analysis of Water 1.0 Objective : To lay down a Procedure for microbiological analysis of Water. 2.0 Scope : This SOP is applicable in Microbiology for microbiological analysis of water. 3.0 Procedure - Microbiological Analysis of Water: Microbiologist shall…
Guideline and Formats for Microbiological Environmental Monitoring (EM) of various area like in Production, Microbiology laboratory, Dispensing & Sampling Area, and Manufacturing Area etc. Microbiological Environmental Monitoring (EM) 1.0 Objective : To lay down a procedure for microbiological of environmental monitoring. 2.0 Scope : This SOP is applicable for microbiological environmental monitoring of area in Production, Microbiology laboratory, Dispensing &…
The Microbial limit test (MLT) is performed to assess how many and which of certain viable microorganisms are present in non-sterile pharmaceutical, healthcare or cosmetics manufacturing samples that range from raw materials to finished products. Microbial limit test (MLT) 1.0 Objective : To lay down a procedure for microbial limit test (MLT). 2.0 Scope : This SOP is applicable in…
Standard Operation Procedure (SOP) of providing training and qualification of analyst for all new appointed personnel, and existing employees who are responsible for sampling & testing of incoming materials, in process samples and finished products. Analyst Qualification Procedure 1.0 Objective : To lay down a procedure of providing training and qualification of analyst for all new appointed personnel, and existing…
Guideline for Laboratory Standard Management (Preparation, Qualification and Handling of Analytical standards/Working Standard/Primary Standard etc.) Working Standard Management 1.0 Objective : To lay down a procedure for the Preparation, Qualification and Handling of Analytical standards (Working Standard, Reference Standard & Primary Standards). 2.0 Scope : This SOP is applicable in Quality Control for the Preparation, Qualification and Handling of Analytical…
Standard Operating Procedure (SOP) and Guideline for sampling of raw material (API and Excipient) / Starting material for analysis. Raw Material Sampling Procedure 1.0 Objective : To lay down a procedure for sampling of raw materials. 2.0 Scope : This SOP is applicable for sampling of raw materials at pharmaceutical drug manufacturing plant. 3.0 Procedure :…
Standard Operating Procedure for Operation and Cleaning of Tablet Compression Machine, the basic principle behind the compression machine is the hydraulic pressure. Tablet Compression Machine 1.0 Objective : To lay down the procedure for cleaning and operation of Tablet Compression Machine (35 Station). 2.0 Scope : This SOP is applicable in Manufacturing Area Tablet at pharmaceutical drug manufacturing plant. 3.0 …
Standard Operating Procedure for Operating, Calibrating and Cleaning of Moisture Analyzer Balance used to determine the moisture content in bulk or granulated material during manufacturing of drug product. Moisture Analyzer Balance 1.0 Objective : To lay down the procedure for cleaning, operation and calibration of Moisture Analyzer Balance. 2.0 Scope : This SOP is applicable in Manufacturing Area for cleaning,…
Standard Operating Procedure for Operation and Cleaning of Auto Coater - Automatic Coating Machine used for Tablet Coating during manufacturing of pharmaceutical solid dosages form. Auto Coater - Automatic Coating Machine 1.0 Objective : To lay down the procedure for cleaning and operation of Auto Coater- Automatic Coating Machine. 2.0 Scope : This SOP is applicable in Tablet Manufacturing Area …
Standard Operating Procedure and Guideline for Cleaning & Operation of Fluidized Bed Dryer (FBD) and Finger Bags (FBD Bags) which is used to drying of granulated materials during manufacturing of solid oral doses forms in pharmaceuticals. Procedure for Operation & Cleaning of Fluidized Bed Dryer (FBD) 1.0 Objective : To lay down the procedure for cleaning & operation of Fluidized…
SStandard Operating Procedure (SOP) and Guideline for Operation and Cleaning of Rapid Mixer Granulator (RMG) used in granulation section of Oral solid dosage form at pharmaceuticals drug manufacturing plant. Rapid Mixer Granulator (RMG) 1.0 Objective : To lay down the procedure for cleaning and operation of Rapid Mixer Granulator (RMG). 2.0 Scope : This SOP is applicable in Granulation area…
Guideline for In Process Quality Control (IPQC) check during manufacturing of different pharmaceutical dosage form like Oral Liquid, Tablets & Capsules. In Process Quality Control (IPQC) check 1.0 Objective : To lay down procedure for checking of in-process parameters of Oral Liquids, Tablets & Capsules. 2.0 Scope : The SOP is applicable in Production during capsule filling, liquid filling, compression,…
Standard Operating Procedure (SOP) for Handling of Out of Trend (OOT) results during Stability Study of Drug Product. Out of Trend (OOT) Result 1.0 OBJECTIVE : To lay down a procedure for handling of Out of Trend (OOT) encountered during analysis and during stability study of Drug Product. 2.0 SCOPE : This SOP is applicable to all the Out of…
Standard Operating Procedure (SOP) and Guideline for Handling of Out of Calibration (OOC) results of Laboratory Instruments and Equipment like HPLC system, UV Spectrophotometers, Polarimeters etc. Handling Out of Calibration (OOC) Results 1.0 OBJECTIVE : To lay down a procedure for the handling out of calibration (OOC) results of Laboratory Instruments and Equipment. 2.0 SCOPE : This SOP is applicable…
Standard Operating Procedure & Guideline for Hold Time Study of Drug Product at different manufacturing stages like bulk granules/powder, blend, bulk liquids, core tablets, coated tablets, filled capsule, binder and coating solution etc. Hold Time Study Procedure 1.0 Objective : To lay down the procedure for conducting the hold time study of pharmaceutical products during manufacturing at every stage. 2.0 …
Standard Operating Procedure and Guideline for New Product Introduction in existing set of product list and equipment trail and Quality Risk Management at Pharmaceuticals Drug Manufacturing Plant. Guideline for Introduction of Product 1.0 Objective : To lay down the procedure for introduction of new product at the manufacturing location. 2.0 Scope : This guideline is applicable for Introduction of new…
Standard Operating Procedure (SOP) for Audit Trail Review for the application software on computer system associated with laboratory instruments. Audit Trial Review 1.0 Objective : To lay down a procedure for Checking of audit trail for the application software on computer system associated with laboratory instruments. 2.0 Scope : This SOP is applicable to Quality Control Department at the pharmaceuticals…
