Microbiology - Pharma Egg

Jan292024 by KBS.No Comments

SOP for Identification of Unknown Microorganisms

A Standard Operating Procedure SOP for Identification of Unknown Microorganisms is crucial in a microbiology laboratory to ensure consistency, accuracy, and safety in the process. Keep in mind that specific procedures may vary based on the laboratory's equipment, resources, and protocols. PURPOSE To describe the procedure for the identification of bacteria as Gram Negative and Gram Positive up to specie level SCOPE This procedure is applicable to elucidate the morphology arrangement of bacterial cells. RESPONSIBILITIES & AUTHORITIES Manager Quality Control is responsible to ensure that procedure & formats are followed entirely as approved. Microbiologist is responsible to perform the test. REFERENCES & REQUIREMENTS USP DEFINITIONS & ABBREVIATIONS Gram Sta...

Jan292024 by KBS.No Comments

GMP Questionnaire for Excipients

Raw Material, General SOPS, General Topics, Microbiology, Product, Production, Quality Assurance, Quality Control, SOPs, Testing Methods

A Good Manufacturing Practice GMP Questionnaire for Excipients is a tool used to assess and qualify excipient suppliers to ensure compliance with regulatory standards and quality requirements. Part I: To be Completed by Supplier A) Contact Details Name: Address: Postal Code, City: Country: Telephone / fax / E-mail: Contact Person: Is your company the subsidiary of another company or corporation? Yes No If yes, please state name of parent company: Number of local employees: What services do you offer? (enclose a description, if applicable) Is your company certified according to MP (if yes, please enclose certificate) Yes No Part II: To be Completed by Manufacturer Only I confir...

Jan282024 by KBS.No Comments

SOP for Supplier Qualification of Excipients

Microbiology, Quality Control, SOPs

A Standard Operating Procedure SOP for Supplier Qualification of Excipients is essential to ensure the quality, safety, and regulatory compliance of the materials used in pharmaceutical and other industries. Excipients are critical components of drug formulations, and it is crucial to establish a systematic process for qualifying and approving suppliers. Purpose To describe procedure for selection, qualification and approval of Excipient’s supplier including domestic and foreign manufacturer To establish a standardized process for the qualification of suppliers providing excipients. To ensure the quality, safety, and regulatory compliance of excipients used Pharmaceuticals products. Scope The scope of this document pertains to suppliers of all excipients used in Pharmac...

Jan282024 by KBS.No Comments

Sterility Test of Large Volume Products by Filtration Method

Microbiology, General Topics, Quality Control, SOPs

A Sterility Test is a critical procedure in pharmaceutical and biopharmaceutical industries to ensure that large volume parenteral products are free from viable microorganisms. The filtration method is commonly employed for the sterility testing of large volume products. Below is a general outline for an SOP for Sterility Test of Large Volume Products by Filtration Method PURPOSE To assure the sterility of aseptically, terminal sterilized filled large volume products. To establish a standardized procedure for conducting Sterility Tests on large volume parenteral products. To ensure the absence of viable microorganisms in large volume products intended for parenteral administration. SCOPE This SOP is applicable to aseptically, terminal sterilized filled large volume prod...

Jan32024 by XhaamiNo Comments

Classification of HVAC Systems in Pharmaceuticals

Instrument SOP, Microbiology, Production, SOPs

In the pharmaceutical industry, the proper control of temperature and air quality is essential for ensuring the quality, safety, and efficacy of products. Classification of HVAC Systems in Pharmaceuticals (heating, ventilation, and air conditioning) systems play a crucial role in maintaining the required conditions for pharmaceutical manufacturing, storage, and distribution. The HVAC system helps to maintain cleanroom conditions, regulate temperature and humidity levels, and provide fresh and filtered air. Pharmaceutical facilities often require a high level of control over environmental conditions to meet regulatory requirements, prevent contamination, and ensure product stability. The Classification of HVAC Systems in Pharmaceuticals is a critical component of the overall environmenta...

Jan12024 by KBS.No Comments

SOP for Operation of Drying Oven

SOPs, Microbiology, Quality Control

The purpose of this SOP for Operation of Drying Oven is to provide guidelines for the safe and effective operation of the drying oven at pharmaegg.com This SOP ensures that all personnel are aware of the proper procedures for using the drying oven to maintain product quality and prevent accidents. PURPOSE of SOP for Operation of Drying Oven To lay down a procedure for the operation of Drying Oven. SCOPE This SOP is applicable for the operation of a drying oven used for the depyrogenation of the glassware in the microbiology lab of the Pharmaceuticals. RESPONSIBILITIES & AUTHORITIES Microbiologists are responsible for the operation of dry heat oven as per SOP. Microbiology Head is responsible for the preparation and implementation of this SOP as well as for the operation of...

Dec102023 by KBS.No Comments

SOP for BET by Gel Clot Method

Microbiology, Quality Control, SOPs

A Standard Operating Procedure (SOP) for the Bacterial Endotoxin Test (BET) by the Gel Clot Method outlines the step-by-step instructions for performing the test. Below is a general template for an SOP for BET by Gel Clot Method. Keep in mind that specific details may vary depending on the manufacturer's instructions and your laboratory's specific requirements. SOP for BET by Gel Clot Method Be sure to consult relevant guidelines and regulations. PURPOSE This procedure has been established to provide the guidelines for LAL testing by Gel Clot Method in Microbiological lab to ensure the quality and purity of microbiological products. This provides a test for estimating a concentration of Bacterial Endotoxin that may be present in or on sample of the article to which the test is app...

Dec92023 by KBS.No Comments

Procedure for Training of the Personnel Under cGMP Environment

General SOPS, Microbiology

Training personnel under Current Good Manufacturing Practices (cGMP) is crucial for maintaining the quality and compliance of pharmaceutical and other regulated products. Here's a general Procedure for Training of the Personnel Under cGMP Environment PURPOSE The purpose of this SOP is to describe the procedure for training of the Procedure for Training of the Personnel Under cGMP Environment at Pharmaceutical Industries Limited. Based on the identified needs, develop a comprehensive training plan. This plan should outline the training objectives, content, methods, resources, and a timeline for implementation. SCOPE The scope of this SOP pertains to all the persons working at Pharmaceutical Industries Limited. Conduct a thorough analysis to identify training needs. This may include asse...

Dec92023 by KBS.No Comments

SOP for Operation of Autoclave Use in Pharmaceutical Industry

Instrument SOP, Microbiology, SOPs

A Standard Operating Procedure SOP for Operation of Autoclave Use in Pharmaceutical Industry is crucial to ensure the proper sterilization of equipment, materials, and products. Here's an example SOP outline for the operation of an autoclave. This example SOP serves as a general guideline. Adjustments should be made to align with the specific equipment and procedures within your pharmaceutical facility. Regular review and updates to SOPs are necessary to ensure compliance with current industry standards and regulations. PURPOSE To lay down a procedure for the operation of steam sterilizer (Autoclave). The objective of this SOP is to outline the proper procedures for the safe and effective operation of the autoclave to achieve sterilization of equipment, materials, and products in comp...

Nov152023 by KBS.No Comments

Sop for Cleaning, Mopping and Fumigation of Sterility Room

Microbiology, General SOPS, SOPs

Certainly! Below is a template for a Standard Operating Procedure SOP for Cleaning, Mopping, and Fumigation of a Sterility Room. This SOP is essential for maintaining a sterile environment in facilities such as pharmaceutical or biotechnology cleanrooms. Ensure that this SOP complies with any applicable regulatory guidelines and industry standards. Additionally, adapt the template to match the specific requirements and processes of your organization. Regularly review and update the SOP to reflect any changes in procedures or equipment. PURPOSE To describe the procedure for cleaning, mopping and fumigation of the sterility test Lab to avoid area / equipment generated Microbial contamination in sterility test Lab. SCOPE This procedure applies to sanitization by disinfecting mopping an...