In the Quality Control Laboratory of the pharmaceutical product manufacturing unit, Different instruments, and equipment being used to analyze the drug product. the documented tracking or list of activities known as the Audit trail. An audit trail can be either a paper or electronically based trail that provides a documented history of a transaction within […]

Standard Operating Procedure (SOP) for Isolation and Identification of Microorganisms (Microbes). Isolation and Identification of Microorganisms 1.0      PURPOSE: To lay down the Procedure for Isolation and Identification of Microorganisms. 2.0     SCOPE: This Standard Operating Procedure is applicable to the Microbiology Department at the pharmaceutical manufacturing unit. 3.0      REFERENCE: SOP for […]

Quality Risk Management: An overall and continuing systematic process for the assessment, control, communication and review of risks to the quality of a pharmaceutical product or medical device across the product lifecycle in order to optimize its benefit-risk balance. SOP for Quality Risk Management 1.0       PURPOSE: This Standard Operating Procedure  (SOP) establishes uniform […]

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 Product Recall 1.0      PURPOSE The purpose of this SOP is Effective and speedy withdrawal/ removal of […]

Standard operating procedure (SOP) for change control management. Change Control Procedure is a formal controlled documented process by which qualified representatives from appropriate discipline, review, propose and make changes to an approved system. SOP for Change Control Management 1.0       PURPOSE: This standard operating procedure defines the requirements to ensure changes to systems (includes […]

Standard Operating Procedure (SOP) for maintenance of laboratory instrument i.e. preventive maintenance, breakdown maintenance, etc. SOP for Maintenance of Laboratory Instrument 1.0      Purpose: The purpose of this SOP (Standard Operating Procedure) is to describe the procedure of instrument maintenance and preventive maintenance.  2.0     Scope: This procedure is applicable to the Instruments at […]

Standard Operating Procedure (SOP) for GC Columns, Receipt, performance check, usage, and maintenance of Gas Chromatography Column. SOP for GC Column: Receipt, Storage, Performance Check, Uses and Care 1.0       Purpose: The purpose of this SOP is to describe the procedure for the receipt, performance check, usage, and maintenance of GC Column. 2.0    […]

Standard Operating procedure for receipt and storage of raw material. Starting material such as API and excipient required in the manufacturing of drug product. Receipt and Storage of Raw Material  1.0       PURPOSE: The purpose of this SOP is to define the procedure for receipt and storage of raw materials used in various products. […]

Standard Operating Procedure (SOP) for disintegration apparatus (DT Apparatus) for operation and calibration as per IP containing various calibration parameters. Operation and Calibration of Disintegration Apparatus (DT) 1.0       PURPOSE: The purpose of this SOP is to describe the procedure for operation, calibration, and cleaning of the disintegration apparatus. 2.0      SCOPE: This […]

Standard Operating Procedure (SOP) for HOIST, containing Operation of L.T ElevatorOperation of Hyundai Elevator, Safety Precautions, etc. SOP for HOIST 1.0       PURPOSE: The purpose of this SOP is to define the procedure for the operation of the hoist. 2.0      SCOPE: This procedure is applicable to the operating procedure of Hoists at […]

Standard Operating Procedure for operation and cleaning of the colloid mill. contains Checks & Precautions, Cleaning procedure for product to product changeover, batch to batch changeover, etc. SOP for Operation and Cleaning of Colloid Mill 1.0       Purpose: The purpose of this SOP is to define the cleaning and operating procedure for Colloid Mill. 2.0  […]

Standard Operating Procedure (SOP) for operation and calibration of analytical balances. As per USP, balance calibration parameters are Internal adjustments, Linearity, Sensitivity, Repeatability (Uncertainty), and Accuracy, etc.  SOP for Analytical Balance: Operation and Calibration 1.0      PURPOSE The purpose of this SOP is to describe the procedure of Operation, Calibration, and Maintenance of Analytical […]

Standard Operating Procedure (SOP) for Analytical Solution Stability.  Procedure for stability study of solutions such as standard preparation, impurity solution, and system suitability solution, etc. SOP for Analytical Solution Stability 1.0       PURPOSE: The purpose of this SOP is to define the procedure for the solution stability (Use before date determination of solution(s) used […]

Standard Operation Procedure and Formats of ETP Effluent Treatment Plant  & Sewage Treatment Plant (STP) are defined below. For SOP, please click. SOP for Effluent Treatment Plant (ETP) and STP Annexure and Formats of ETP and STP 1.0      Daily ETP Performance & Operation Record (ETP Formats / Annexure 1) Date: _______________      […]

The manufacturer or supplier who is supplying the material in routine and registered for the supply of specific material after the approval process considered as an approved vendor. Vendor management consists of the Identification, Qualification, Requalification, management of changes at the vendor site, Vendor Audit, Technical Agreement, Deregistration Process, etc. Vendor Management 1.0       […]