This category includes Quality Assurance SOP’s.

Microbiological Analysis of Water – Procedure

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…

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Environmental Monitoring : Microbiological Analysis

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 &…

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Microbial limit test (MLT) – Testing Procedure

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…

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Analyst Qualification of Quality Control Personnel

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…

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Working Standard Qualification Procedure

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…

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Raw Material Sampling Procedure-API & Excipient

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 :…

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Tablet Compression Machine – Operation & Cleaning

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 …

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Moisture Analyzer Balance – Operation & Calibration

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,…

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Auto Coater – Operation & Cleaning Procedure

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 …

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Fluidized Bed Dryer (FBD) – Operation & Cleaning

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…

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Rapid Mixer Granulator (RMG) – Operation & Cleaning

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…

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In Process Quality Control (IPQC) Check Procedure

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,…

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Out of Trend (OOT) Results in Stability Study

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…

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Out of Calibration (OOC) of Laboratory Instruments

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…

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Hold Time Study of Pharmaceutical Products

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 …

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New Product Introduction Procedure and QRM

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…

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Audit Trail Review – Procedure and Schedule

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…

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Technology Transfer Procedure of Drug Product

Guideline for Technology Transfer. Tech Transfer is a systematic procedure that contains the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacture sites to produce similar quality products. It is a systematic procedure that is followed in order to pass the documented knowledge and experience gained during development and or commercialization…

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Market Complaint Handling Procedure of Drug Product

Standard Operating Procedure (SOP) & Guideline for Handling of Market Complaint of Drug Product. Any complaint, written or verbal, received directly from the customer, retailer, distributor, field staff or any Government Agencies regarding purity, labeling defects, shortages etc. such complaints shall be considered as a market complaint. Handling of Market Complaint 1.0   Objective : To lay down the procedure for…

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Acceptable Quality Limit (AQL) Procedure & Chart

Standard Operating Procedure (SOP) and Guideline for the classification of different types of Quality defects that may be encountered in Tablets/Capsules and the Acceptance Quality Limits (AQL) for the same. Acceptable Quality Limit (AQL) 1.0   Objective : To lay down a procedure for the classification of different types of Quality defects that may be encountered in Tablets/Capsules and the Acceptance…

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