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

Oct252023 by KBS.No Comments

Standard Operating Procedure for Product Development

Quality Assurance, Production, SOPs

Developing a Standard Operating Procedure for Product Development is crucial for ensuring consistency, quality, and efficiency in the development process. Here's a general outline for creating an SOP for product development. Please tailor this outline to fit the specific needs and processes of your organization and industry: PURPOSE To define and document a procedure for pharmaceutical product development. SCOPE This procedure applies to development of new pharmaceutical product. RESPONSIBILITIES The Managing Director (MD / CEO) approves the initiation of the project. New Product Technical Committee (NPTC) is responsible for designing and documenting inputs and outputs of design and development activities. This committee comprises of: Executive Director (Technical) ...

Oct252023 by KBS.No Comments

Bacterial Endotoxins Test LAL Test (End Point Chromogenic Method)

Microbiology, General Topics, SOPs, Testing Methods

It's important to note that the Bacterial Endotoxins Test LAL Test (End Point Chromogenic Method), is highly sensitive and specific. It's crucial to follow proper protocols and standards to ensure accurate and reliable results, especially in industries where product safety is paramount. The Limulus Amebocyte Lysate (LAL) test is a widely used method for detecting bacterial endotoxins. Endotoxins are heat-stable toxins present in the outer membrane of Gram-negative bacteria. These toxins can cause severe reactions in humans and animals, so it's crucial to detect and quantify their presence, especially in medical devices and pharmaceutical products. The LAL test operates on the principle that the LAL enzyme in the horseshoe crab's blood reacts with bacterial endotoxins, leading to a ge...

Oct242023 by KBS.No Comments

SOP for the preparation of Master Formula Record

SOPs, Production, Quality Assurance, Quality Control

SOP for the preparation of Master Formula Record Some basic explanations and instructions were given for preparing various documents required by Good Manufacturing Practice guidelines from WHO and from several regulatory authorities. GMP guidelines include the requirements for documents (individual), documentation (the systems and formats for documents), and documenting (recording) of production and control activities. Most GMP guidelines provide the same or very similar information as the principles of Good Manufacturing Practice are now international in scope. In this guidance document, the requirement for master manufacturing instructions and the requirements as given in different GMP documents, Terms for Master Formula (MF) WHO identifies manufacturing instructions as “Master Formula. ...

Oct212023 by KBS.No Comments

Lamotrigine Tablet 25mg 50mg and 100mg Testing By UV and HPLC Method

Testing Methods, Product, SOPs

Testing Lamotrigine tablets (100mg) using UV (Ultraviolet) spectroscopy and HPLC (High-Performance Liquid Chromatography) are common methods Lamotrigine Tablet 25mg 50mg and 100mg Testing By UV and HPLC Method in pharmaceutical analysis to determine the concentration and purity of the active pharmaceutical ingredient (API) in the formulation. Here's a brief overview of how you can perform these tests: PURPOSE: To describes the procedure for analysis at in-process and finished stage of Lamotrigine Tablet 25mg 50mg and 100mg Testing By UV and HPLC Method. SCOPE: This SAP gives detailed outline for the finished product analysis of Lamotrigine Tablet 25mg 50mg and 100mg Testing By UV and HPLC Method and will cover In process testing activities on physical, chemical & instrumental basis...

Oct212023 by KBS.No Comments

Clopidogrel 75mg Tablet Testing by Ultraviolet (UV) Spectroscopy

Testing Methods, Product, SOPs

It seems like you are referring to the testing of Clopidogrel 75mg Tablet Testing by Ultraviolet (UV) Spectroscopy UV spectroscopy is a common technique used in pharmaceutical analysis to determine the concentration of a substance in a sample based on its absorption of ultraviolet light. However, the specific details about the testing of Clopidogrel 75mg Tablet using UV spectroscopy, such as the methods, results, or any ongoing studies, would require access to recent research papers or publications in the field of pharmaceutical analysis. PURPOSE : To describes the procedure for analysis at in-process and finished stage of clopidogrel 75mg Tablet. SCOPE: This SAP gives detailed outline for the finished product analysis of clopidogrel 75mg Tablet and will cover In process testing activi...

Oct162023 by KBS.No Comments

Atorvastatin Tablets Finish Product Testing Procedure By UV and HPLC Method

Testing Methods, Product, SOPs

Atorvastatin Tablets Finish Product Testing Procedure By UV and HPLC Method like any other pharmaceutical product, is a crucial part of ensuring their safety, efficacy, and quality. Here's an overview of the typical testing procedures involved in the production and quality control of Atorvastatin tablets: It's essential to note that specific testing procedures may vary depending on the country, regulatory agency, and pharmaceutical company. Manufacturers must adhere to good manufacturing practices (GMP) to maintain the quality and consistency of their products. The goal of these testing procedures is to ensure that Atorvastatin tablets are safe, effective, and of high quality, providing patients with the expected therapeutic benefits while minimizing risks and maintaining product con...

Oct162023 by KBS.No Comments

Linezolid 600mg film-coated Tablets Finish Product Testing Procedure

Testing Methods, Product, SOPs

Linezolid 600mg film-coated Tablets Finish Product Testing Procedure, like other pharmaceutical products, is a critical step in ensuring their safety, efficacy, and quality. Below is an overview of the typical testing procedures involved in the production and quality control of Linezolid tablets: It's essential to note that specific testing procedures may vary depending on the country, regulatory agency, and pharmaceutical company. Manufacturers must adhere to good manufacturing practices (GMP) to maintain the quality and consistency of their products. The goal of these testing procedures is to ensure that Linezolid 600 mg tablets are safe, effective, and of high quality, providing patients with the expected therapeutic benefits while minimizing risks and maintaining product consiste...

Oct162023 by KBS.No Comments

Rifaximin 550 mg Tablets Finish Product Complete Testing Procedure

Testing Methods, Product, SOPs

The Rifaximin 550 mg Tablets Finish Product Complete Testing Procedure, like other pharmaceutical products, is essential to ensure their safety, efficacy, and quality. Below is an overview of the typical testing procedures involved in the production and quality control of Rifaximin tablets. The goal of these testing procedures is to ensure that Rifaximin 550 mg tablets are safe, effective, and of high quality, providing patients with the expected therapeutic benefits while minimizing risks and maintaining product consistency. Please note that specific testing procedures may vary depending on the country, regulatory agency, and pharmaceutical company. Manufacturers must adhere to good manufacturing practices (GMP) to maintain the quality and consistency of their products. PURPOSE: T...

Jul272023 by KBS.No Comments

Procedure for Analysis at the In-process and Finished Stage of the Mecobalamin 500mcg Tablet

Testing Methods, Product, SOPs

Analyzing Mecobalamin 500mcg tablets at both the in-process and finished stages is essential to ensure the quality, safety, and efficacy of the product. The analysis involves various tests and quality control measures. Below is a general Procedure for Analysis at the In-process and Finished Stage of the Mecobalamin 500mcg Tablet Have the data and results reviewed by authorized personnel, including quality control and quality assurance teams, before approving the product for release or further processing? Always follow approved procedures and protocols specific to your laboratory and adhere to Good Manufacturing Practices (GMP) to ensure the accuracy and reliability of the analysis. This procedure is a general guideline and may need to be adapted based on the specific requirements and...

Jun82023 by KBS.No Comments

SOP for Finished Product Analysis of Misoprostol 200mcg Tablet by HPLC Method

Testing Methods, Product, Quality Control, SOPs

For misoprostol, identification, assay, and related substances were considered essential, given the link to efficacy and the known instability of the product. SOP for Finished Product Analysis of Misoprostol 200mcg Tablet by HPLC Method due to the low ratio of API content to tablet mass and therefore higher risk of non-homogeneity within batches, content uniformity was included. Dissolution or disintegration was not included as misoprostol is a highly soluble substance (19), and anecdotally these parameters are rarely found out of specification (OOS) for misoprostol products. Misoprostol tablets were analyzed for the selected parameters using the methods and specifications described in the International Pharmacopoeia PURPOSE: To describe the procedure for analysis at the in-process and f...