Learn about the Standard procedure for the Sterilized Powder filling machine in the injection section along with their Objective, Scope, Responsibility, Procedure, and cleaning process. 1.0 Objective: To lay down the procedure for efficient Cleaning & Operation of the Sterilized Powder filling machine. 2.0 Scope: This SOP for Cleaning & Operation of a Sterilized Powder filling … Read more
Learn About Standard Operating procedure on the Depyrogenation method and washing of Test tubes for BET. 1.0 Object: 1.1 To lay down the procedure for the Depyrogenation method and washing of test tubes for BET. 2.0 Scop: 2.1 This SOP applies to carry out the procedure of the Depyrogenation method and washing of test tubes for BET in a microbiology laboratory … Read more
In pharmaceutical manufacturing, following entry and exit procedures for staff and visitors is essential to prevent external environmental dust and microorganisms from entering the cleaned area. These procedures also help prevent contamination and cross-contamination within the manufacturing facility. According to WHO pharmaceutical guidelines, a well-defined procedure for on-premises entry and exit must be in place. … Read more
Learn About Standard Operating Procedure for Sterile failure investigation within sterile testing Areas including their, Aim, Scope, Responsibility, Procedure, and Definitions. 1.0 AIM: To lay down the cleaning procedure for the Sterility failure investigation.2.0 SCOPE: This SOP applies to carry out the cleaning procedure for the Sterility failure investigation.3.0 RESPONSIBILITY: Executive – Provide training for Cleaning procedure for the Sterility testing area … Read more
Learn About Standard operating procedure on Laminar airflow in a Micro laboratory including their, Aim, Scope, Responsibility, distribution, Procedure, and Annexures. 1.0 AIM: To lay down the procedure of Operation of Laminar airflow in the microbiology laboratory.2.0 SCOPE: This SOP applies to carry out the procedure Operation of Laminar airflow in the microbiology laboratory at a pharmaceutical plant. 3.0 RESPONSIBILITY:3.1 Executive … Read more
Learn About Standard Operating Procedure for Microbial Incubator operation and their Calibration along with Objective, Scope, Responsibility, Procedure, Frequency, and Tolerance Limits 1.0 Objective: To get reliable and consistent results, we must ensure the procedure and maintenance of the Microbial Incubator, especially for temperature maintenance for Microbial growth. 2.0 Scope: This procedure is applicable to … Read more
Discover the effective process for conducting planned internal quality audits within the pharmaceutical industry. Learn how to optimize quality assurance practices while ensuring compliance with regulatory standards. Gain insights into enhancing pharmaceutical audit procedures and achieving operational excellence. 1.0 PURPOSE: 1.1 The purpose of this procedure is to implement a system for planned internal quality audits … Read more
Learn about Standard Operating procedures for Storage and Movement of unlubricated granules / Transfer including their Purpose, Scope, procedure for Storage of Unlubricated / Graded Granules, transfer of Unlubricated Granules to Blender Room, Precautions, and Annexures. 1.0 Purpose: 1.1 To lay down the Standard Operating Procedure for storage and movement of unlubricated granules and their transfer to … Read more
Learn About Standard Operating Procedures for Storage and labeling of Raw and Packing materials including their, Purpose, Scope, Responsibility, Procedure, Precautions, and Records. 1.0 Purpose: 1.1 The purpose of this SOP is to implement system storage and labeling of Raw and Packing materials in raw material stores.2.0 Scope: 2.1 This SOP is applicable to all raw materials; packaging … Read more
Learn about the Standard Operating procedure on RMG including their, Purpose, Scope, Responsibility, Checkpoints, procedure, cleaning, discharging, and Frequency. 1.0 Purpose: To lay down SOP on Rapid Mixture Granulator for Operation and Cleaning.2.0 Scope: This SOP applies to RMG operation and cleaning In pharmaceuticals.3.0 Responsibility: 3.1 Operator, Officer Production is responsible for the implementation of this SOP.3.2 Head Production is responsible for ensuring compliance with this SOP … Read more
A vibro sifter is used in pharmaceuticals to crush the solid mass of granules and create the desired size of granules using sieves. Let’s understand the cleaning and operation procedures of the vibro sifter. 1.0 Objective: 1.1 To lay down the procedure for Vibro Sifter operation and Cleaning2.0 Aim: This procedure is applied to Vibro … Read more
Learn about the Standard Operating Procedure for the Collection of Swab and Rinse Water Samples, including their purpose, scope, responsibility, procedure for Swab Sampling, Sampling frame, Rinse Water Sampling, and Annexures. 1.0 Purpose: 1.1 To lay down the Standard Operating Procedure for the collection of the swab and rinse water samples2.0 Scope: 2.1 This SOP is applicable to all the … Read more
Learn About Standard Operating Procedure in Cleaning of Quality control department including Their, Aim, Purpose, Responsibilities, Procedure to clean the Floor, Wall, Door, Window, Glass, Ceiling, Air Grill, Waste Bin, Working Bench, Light Fixture, and Drain Point. 1.0 Aim: To lay down the standard operating procedures for cleaning the Quality Control Department in Pharmaceutical. 2.0 Responsibility:2.1 Housekeeping Personnel: … Read more
Learn About Standard Operating Procedure on IPA 70 % Preparation including their, Purpose, Scope, Procedure, frequency, and Annexures. 1.0 Purpose: To lay down the Standard Operating Procedure for the Preparation of 70 percent v/v Isopropyl Alcohol Solution. 2.0 Scope: This SOP applies to the preparation of 70 percent v/v Isopropyl Alcohol Solution. 3.0 Procedure: 3.1 Requisition for Isopropyl … Read more
Learn About the Standard Operating Procedures of Tipper including their, Purpose, Scope, Responsibility, Operation, Cleaning, and Precautions. 1.0 Purpose: To provide the SOP on tipper operation and cleaning. 2.0 Scope: This SOP is applicable for the operation and cleaning of the tipper in the production department at the Plant. 3.0 Responsibility: 3.1 Production Operator:3.1.1 To perform the operation and … Read more
The Standard Operating Procedure (SOP) for the in-process Quality check is applicable to all areas in the production line and packing line at different stages, as described in this SOP. In-process Quality checks are crucial for maintaining product quality and safety at every stage. Purpose: SOP for carrying out in-process Quality checks during the manufacturing and … Read more