This category includes Production Related SOP’s i.e. Manufacturing & Packing
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 & 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…
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…
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…
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…
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…
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…
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…
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 :…
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…
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)…
Standard Operating Procedure for Mock Recall and Drug Product Recall, The drug product recall is a process of removal or correction of marketed products for the reasons relating to deficiencies in quality, safety, or efficacy, including labeling considered to be in violation of the laws. SOP for Mock Recall & Drug Product Recall 1.0 Objective : To lay down a…
Standard Operating Procedure (SOP) for Procedure, Process and Management of Change Control (temporary change or permanent change control) in the pharmaceutical drug manufacturing plant. Change Control Management 1.0 Objective: To lay down the procedure to identify, initiate, evaluate, review, approve, implement, and regularize the change through a change control system. 2.0 Scope - SOP for Change Control: This procedure covers…
Standard Operating Procedure (SOP) for Stability Study of Drug Product as per ICH Q1A(R2). The term (Stability Study) with respect to a drug dosage form refers to the chemical & physical integrity of the dosage unit & when appropriate, the ability of the dosage unit to maintain protection against microbial contamination. Stability Study Guideline 1.0 Objective: To lay down a…
