This category includes Quality Related SOP’s, i.e. Quality Assurance & Quality Control departments

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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Quality Risk Management (QRM) – ICH Q9

Standard Operating Procedure (SOP) & Guideline for Quality Risk Management (QRM) i.e. risk identification, analysis, evaluation, reduction/ mitigation, communication and conclusion of risk in order to ensure the quality, safety, integrity and purity (SISPQ) of the drug product. Quality Risk Management (QRM) 1.0   Objective : To lay down the procedure for risk identification, analysis, evaluation, reduction/ mitigation, communication and conclusion…

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Corrective and Preventive Action (CAPA)

Standard Operating Procedure (SOP) for various investigation tools for finding the root causes that enables determination of corrective and preventive action (CAPA). Handling of Corrective and Preventive Action (CAPA) 1.0   Objective : To describe the procedure describing various investigation tools for finding the root causes that enables determination of corrective and preventive actions. To identify quality issues and GMP issues…

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Batch Manufacturing Record (BMR) Management

Standard Operating Procedure for Preparation, Checking, Approval, authorization & issuance of Master Formula Record, Batch Manufacturing Record (BMR) & Batch Packaging Record (BPR). Batch Manufacturing Record (BMR) & Batch Packaging Record (BPR)  Management 1.0   Objective : To lay down the procedure for Preparation, Checking, Approval, authorization & issuance of Master  Formula Record (MBR), Batch Manufacturing Record (BMR) & Batch Packaging…

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Cleaning Validation (CV) Procedure and Protocol

Standard Operating Procedure (SOP) and Guideline for performing Cleaning Validation (CV) of drug product manufacturing equipments. Cleaning Validation (CV) 1.0   Objective : To lay down the procedure for Cleaning Validation (CV) of manufacturing equipments. This Guideline describes the validation of cleaning procedures (CV) for the removal of contaminants associated with the previous products, residues of cleaning agents as well as…

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Process Validation (PV) & Verification of Drug Product

Standard Operating Procedure (SOP), Guideline and Protocol for Process Validation and Verification for Drug Product (Tablet, Capsule etc.) Process Validation (PV) Procedure 1.0   Objective : To lay down the procedure for Process Validation of pharmaceuticals products. Process validation provides documented evidence that a process is capable of reliably and repeatedly render a product of the required quality. 2.0   Scope :…

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Deviation (Planned and Un-planned) Control System

Standard Operating Procedure (SOP) for identification, Investigation, approval, and trending of Deviation (s) which may occur during manufacturing, packaging, or any other operation/activity. Deviation Control Management 1.0   Objective : To lay down a procedure for identification, Investigation, approval, and trending of Deviation (s) which may occur during manufacturing, packaging or any other operation / activity. This SOP defines key system…

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APQR – Annual Product Quality Review in Pharma

Standard Operating Procedure for Annual Product Quality Review (APQR), also known as Product Quality Review (PQR) and Annual Product Review (APR) preparation. Procedure for Annual Product Quality Review (APQR) 1.0   Objective: To lay down the procedure for carrying out the Annual Product Quality Review (APQR). The purpose of this SOP is to describe the procedure for Product Quality Review (APQR)…

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