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

Oct272023 by KBS.No Comments

SOP OF SOPS (SOP on Standard Operating Procedure)

General SOPS, SOPs

SOP OF SOPS (SOP on Standard Operating Procedure) are documented processes that a company has in place to ensure that services and/or products are consistently delivered every time while meeting minimum quality standards. In practice, most SOPs are written as a step-by-step series of operating instructions that can show employees what they need to do to accomplish a task. SOPs are designed to ensure efficient, quality production on a consistent basis, regardless of who follows them. Purpose: To describe the SOP OF SOPS (SOP on Standard Operating Procedure) for Preparation, Review and Approval of Standard Operating Procedures. Scope: This procedure is applicable to all SOPs at The Searle Company Ltd Lahore. Responsibility: Executive/Officer QA/Designee: Preparation And Revision / Peri...

Oct262023 by KBS.No Comments

Equipment Operational Qualification (SOP)

SOPs, Production, Quality Assurance, Quality Control

Equipment Operational Qualification (SOP) is the process, which establishes through verification and documentation that the equipment is capable of operating within established limits and tolerances. This demonstration of basic performance must involve operational aspects of the equipment that will be routinely used in manufacturing. OBECTIVE: This guideline defines the minimum requirements for facility regarding the Equipment Operational Qualification (SOP) which must be performed following Installation Qualification (IQ) and prior to process, system qualification. SCOPE: All critical equipments will require successful completion of Operational Qualification (OQ). For New Equipment: OQ must be completed prior to manufacture of product for process validation. For existing equi...

Oct262023 by KBS.No Comments

Cleaning Validation Standard Operating Procedure

SOPs, Production, Quality Assurance

Equipment changeover Cleaning Validation Standard Operating Procedure must be validated for all major and minor product contact equipment used for multi-product production, subdivision and sampling of drug products and in process materials. INTRODUCTION Validation of cleaning procedures has generated considerable discussion since agency documents, including the Inspection Guide for Bulk Pharmaceutical Chemicals and the Biotechnology Inspection Guide, have briefly addressed this issue. These Agency documents clearly establish the expectation that cleaning procedures (processes) be validated. This guide is designed to establish inspection consistency and uniformity by discussing practices that have been found acceptable (or unacceptable). Simultaneously, one must recognize that for cleani...

Oct252023 by KBS.No Comments

SOP for Purified Water & Potable Water Testing

SOPs, Microbiology, Quality Assurance

Formula: H2O Molecular Weight: 18 Source of Information: WHO/BP/USP Purpose: To avoid microbial contamination in products. Liquid as well as solids. Water Sampling Point Place Tests and Frequency Purpose SP-1 Between Turbine and Tank Chemical and Microbiological: Once in a Month To prove the chemical quality and microbiology of the well water SP-2 Between Tank and Sand Filter Chemical and microbiological. Fortnightly To prove the chemical quality of the well water and the change of the microbial Quality in the Tank SP-3 After Hardness Stabilizing System (Anti-scaling System) Chemical: Twice a week To prove the effect of the Hardness stabilizing system SP-4 Primary storage tank Chemical: Twice a week To prove the efficacy of 1st two membra...

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...