SOPs

Standard Operating Procedures (SOPs) provides end-users with clear instructions on how to work and develop enough to ensure that all end-users can perform their tasks in a consistent and consistent manner. Many processes can be difficult, and it is important to have a balance between too few and too many points. If there are too few points, the end-user will follow their path. On the other hand, too much information and too much detail increase the risk that the end-user will struggle to understand and perform everyday steps, resulting in errors and omissions.

Sops are of different types like Quality Control SOPs, General SOPs, Production SOps, R&D, Regulatory and Validation SOPs etc

Nov32023 by KBS.No Comments

Standard Operating Procedure (SOP) for Growth Promotion Test

Microbiology, SOPs

This SOP provides a United States Pharmacopoeia guideline for conducting a Growth Promotion Test. Always refer to specific pharmacopeial references and laboratory quality management system guidelines when performing the test for microbiological media used in specific applications. This Standard Operating Procedure (SOP) outlines the steps for conducting a Growth Promotion Test (GPT) to ensure the quality and performance of microbiological media used in the laboratory. Standard Operating Procedure (SOP) for Growth Promotion Test PURPOSE To describe the procedure for the growth promotion test of Medias used in Microbiology Lab for routine testing. SCOPE Procedure is applied to incoming Medias for microbiological tests. RESPONSIBILITIES AND AUTHOROTIES Manager Quality Control is r...

Nov32023 by KBS.No Comments

Standard Operating Procedure (SOP) for Preparation of Peptone Water

Microbiology, SOPs

This Standard Operating Procedure (SOP) outlines the steps for the preparation of Peptone Water, a common microbiological medium used for the cultivation and maintenance of a wide range of microorganisms. Standard Operating Procedure (SOP) for Preparation of Peptone Water PURPOSE This procedure has been established to provide the guidelines for preparation of Peptone Water. SCOPE This procedure is applicable to microbiological section of Quality Control Lab. RESPONSIBILITIES’ & AUTHORITIES Microbiologist is responsible for proper preparation of this culture media. Quality Control Manager is responsible for implementation of this SOP. REFERENCES & REQUIREMENTS Manufacturers COA USP general chapters DEFINITIONS & ABBREVIATIONS Dehydrated culture media: It is a mast...

Nov32023 by KBS.No Comments

SOP for Preparation of Fluid Thioglycollate Medium (FTM)

Microbiology, SOPs

This Standard Operating Procedure (SOP) outlines the steps for the preparation of Fluid Thioglycollate Medium (FTM), a versatile enrichment medium used in microbiological laboratories for the cultivation and maintenance of anaerobic and microaerophilic bacteria. SOP for Preparation of Fluid Thioglycollate Medium (FTM) PURPOSE This procedure has been established to provide the guidelines for preparation of Fluid Thioglycolate Medium. SCOPE This procedure is applicable to microbiological section of Quality Control Lab. RESPONSIBILITIES’ & AUTHORITIES Microbiologist is responsible for proper preparation of this culture media. Quality Control Manager is responsible for implementation of this SOP. REFERENCES & REQUIREMENTS Manufacturers COA USP general chapter...

Nov32023 by KBS.No Comments

Standard Operating Procedure for Preparation of Tryptic Soya Broth

Microbiology, SOPs

This Standard Operating Procedure for Preparation of Tryptic Soya Broth outlines the steps for the preparation of Tryptic Soya Broth, a commonly used medium in microbiology for the cultivation of a wide variety of microorganisms. PURPOSE This Standard Operating Procedure for Preparation of Tryptic Soya Broth has been established to provide the guidelines for preparation of Tryptic Soy Broth. SCOPE This procedure is applicable to microbiological section of Quality Control Lab. RESPONSIBILITIES & AUTHORITIES Microbiologist is responsible for proper preparation of Standard Operating Procedure for Preparation of Tryptic Soya Broth culture media. Quality Control Manager is responsible for implementation of this Standard Operating Procedure for Preparation of Tryptic Soya Broth ...

Nov22023 by KBS.No Comments

Guidelines for Equipment Installation Qualification (SOP)

Quality Control, General SOPS, SOPs

The purpose of this procedure is to outline the Guidelines for Equipment Installation Qualification (SOP) requirements and acceptance criteria for the critical equipment serving to Pharmaceutical Limited facility. This Standard Operating Procedure outlines the guidelines for Equipment Installation Qualification (IQ) at pharmaegg.com. Guidelines for Equipment Installation Qualification (SOP) is a critical step in ensuring that newly acquired equipment is properly installed, calibrated, and ready for use. Adhering to these guidelines guarantees the integrity, accuracy, and reliability of the equipment, contributing significantly to the quality and consistency of our research and development efforts. OBECTIVE: Guidelines for Equipment Installation Qualification (SOP) location and purpose of...

Nov22023 by KBS.No Comments

Reverse Osmosis Water System (SOP)

General SOPS, General Topics, Quality Control, SOPs

1.0 RAW WATER Reverse Osmosis Water System (SOP) is that water, which is obtained from well or any reservoir. Reverse Osmosis Water System (SOP) contains minerals, salts chlorides, sulfates, calcium & magnesium etc. Microbial count of raw water, which may be used for drinking, is 500CFU/ml. The ingredients present in this water may be incompatible with our medicine and can disturb the stability of product so, purification of this water is required. 2.0 PURIFIED WATER Purified water is that water which is obtained by distillation, ion exchange treatment, reverse osmosis or other suitable process from suitable potable water. It contains no added substances Purified water is required for manufacturing of quality medicine in Searle P...

Nov22023 by KBS.No Comments

General Descriptions of Quality Control Department

Quality Control, General SOPS, General Topics, SOPs

1.0 INTRODUCTION General Descriptions of Quality Control Department is a concept which stocks to produce a perfect product by series of measure design to prevent and eliminate errors at different stages of products. It is the most essential component of the drug industry and quality control may be easy for a well equipped and qualified staff i.e. as the necessary facilities including analytical instruments like HPLC, UV, K.F, and other necessary instruments as well as required chemicals. Q.C is essentially concerned with routine examination of a limited range of raw material intermediate and finished products. The laboratory is usually required to carryout the following type of testing, chemical analysis, instrumental analysis, general microbiological testing and r...

Nov22023 by KBS.No Comments

SOP for Calibration and Operation of Cool Incubator

Instrument SOP, General Topics, Microbiology, SOPs

This Statement of Purpose outlines the procedures and guidelines for the proper SOP for Calibration and Operation of Cool Incubator at pharmaegg.com. The cool incubator is essential for maintaining low-temperature conditions for various biological and chemical experiments, making it crucial to adhere to strict calibration and operational protocols. Adhering to these protocols ensures accurate and reliable results, contributing significantly to the scientific integrity of our research activities. PURPOSE To describe procedures for operation and calibration of Cooled Incubator. The primary objective of this SOP for Calibration and Operation of Cool Incubator is to establish a standardized approach for the calibration and operation of the cool incubator. By following these guidelines, we ai...

Nov22023 by KBS.No Comments

SOP for Calibration and Operation of Incubator

Instrument SOP, Quality Control, SOPs

This Statement of Purpose outlines the procedures and guidelines for the proper calibration and operation of the incubator at pharmaegg.com, SOP for Calibration and Operation of Incubator plays a crucial role in maintaining optimal conditions for various biological and chemical experiments. Adhering to strict calibration and operational protocols ensures accurate and reliable results, contributing to the overall scientific integrity of our research activities. PURPOSE To describe procedures for operation and calibration of Incubator. The primary objective of this SOP for Calibration and Operation of Incubator is to establish a standardized approach for the calibration and operation of the incubator. This SOP aims to guarantee the consistency and precision of experimental conditions, prom...

Nov22023 by KBS.No Comments

SOP for Operation of Air Sampler

Instrument SOP, General Topics, SOPs

This SOP for Operation of Air Sampler outlines the procedures for the proper operation of the air sampler to ensure accurate and reliable air quality monitoring within the [Your Organization Name] facility. PURPOSE To describe the procedure for the operation of the air sampler. SCOPE This procedure is applicable for the operation of an air sampler at the microbiological laboratory of QCD and the Manufacturing area. This SOP applies to all personnel responsible for operating the air sampler within the organization. RESPONSIBILITIES & AUTHORITIES It is the responsibility of microbiologist to follow this SOP as it is written It is the responsibility of QC manager to review and update this SOP as necessary and to ensure that this SOP is followed in its entirety. REFERENCES ...