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SOP for Reporting and Handling of Deviation

SOP for Reporting and Handling of Deviation

Quality Assurance, Production, Quality Control, SOPs
SOP for Reporting and Handling of Deviation to ensure timely and effective reporting and handling of deviations in pharmaceutical processes to maintain product quality and compliance with regulations Purpose To describe procedure for reporting and handling of deviation(s) Scope SOP for Reporting and Handling of Deviation The scope of this document pertains to all the departments responsible for carrying activities related to the manufacturing of the products at Pharmaceuticals. Responsibilities It is the responsibility of QA to prepare, manage and properly implement this SOP It is the responsibility of all the departments to intimate QA prior to do or immediately after occurrence of any deviation from the written approved procedure It is the responsibility of QA to trigger ...
Types of Pharmaceuticals Waste and Disposal Procedure

Types of Pharmaceuticals Waste and Disposal Procedure

Quality Assurance, Production, Quality Control, SOPs
Pharmaceutical waste encompasses various Types of Pharmaceuticals Waste and Disposal Procedure including expired or unused medications, contaminated materials from pharmaceutical manufacturing processes, and even packaging materials. Here are some common Types of Pharmaceuticals Waste and Disposal Procedure and general disposal procedures. INTRODUCTION The destruction of wastage materials is particularly important. A potential source of contamination shall be eliminated through comprehensive program of disposal. The garbage shall be destructed or removed frequently and thoroughly in accordance with the written program approved by Quality Control Department. Garbage consists of different waste materials, waste materials shall not be allowed to accumulate and it shall be collected in su...
SOP for Art Work of New Pharmaceuticals Products

SOP for Art Work of New Pharmaceuticals Products

Quality Assurance, General Topics, Production, Quality Control, SOPs
Creating the SOP for Art Work of New Pharmaceuticals Products artwork for new pharmaceutical products involves designing the visual elements that will appear on their packaging. This includes things like the logo, brand name, dosage information, and any images or graphics. The goal is to make the packaging informative, attractive, and compliant with regulations, while also reflecting the brand's identity. Think of it as designing the face of the product that customers will see on the shelves. INTRODUCTION The artwork serves multiple vital functions. Firstly, it communicates essential information to healthcare professionals and consumers, ensuring safe and effective use of the medication. Secondly, it plays a significant role in brand recognition and differentiation, helping the product s...
Batch Document Review and Inprocess Checks SOP

Batch Document Review and Inprocess Checks SOP

Quality Assurance, General SOPS, General Topics, Production, Quality Control, SOPs
Batch Document Review and Inprocess Checks SOP are essentially a way to ensure quality and consistency during the manufacturing process. Here's a simplified explanation: Batch Document Review: Before making a batch of products, you review all the documents related to the manufacturing process. This includes recipes, instructions, and quality standards to ensure everything is correct and ready to go. In-process Checks: While making the products, you perform regular checks to make sure everything is going according to plan. This could involve measuring ingredients, checking temperatures, or inspecting the product at different stages to catch any issues early on. These steps help maintain quality control and ensure that the final products meet the desired standards. OBJECTIVE  ...
SOP for General Description of Finished Products

SOP for General Description of Finished Products

Quality Control, General SOPS, General Topics, Product, Quality Assurance, SOPs
SOP for General Description of Finished Products provides a basic overview of the products once they're fully made. It typically includes details like what the product looks like, its size, color, materials used, and any unique features or characteristics. Think of it as a snapshot that helps someone understand what the product is all about without getting into too much technical detail. INTRODUCTION A finished product is any pharmaceutical product that has under gone all stages of production, including packing and labeling. The efficacy and safety of a product can only be assured by analytical monitoring of its quality therefore, the overall purity of a product must therefore, be assessed throughout its manufacturing, storage, distribution and use. The objective can easily be achi...
SOP for Identification of Unknown Microorganisms

SOP for Identification of Unknown Microorganisms

Microbiology, Quality Control, SOPs
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...
GMP Questionnaire for Excipients

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...
SOP for Supplier Qualification of Excipients

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...
Sterility Test of Large Volume Products by Filtration Method

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...
Sampling and Testing of Intermediate and Finished Goods

Sampling and Testing of Intermediate and Finished Goods

Quality Control, General Topics, SOPs
The Sampling and Testing of Intermediate and Finished Goods are crucial steps in the quality control and assurance processes within manufacturing and production industries. These processes ensure that products meet the specified quality standards and conform to regulatory requirements. PURPOSE To outline a procedure to take samples of Intermediate and Finished Material. The purpose of this procedure is to outline the systematic process for sampling and testing of intermediate and finished goods to ensure they meet quality specifications and regulatory standards. SCOPE: This SOP applies to sampling of intermediate materials and Finished Materials. RESPONSIBILITIES: Production Incharge, QC Incharge and QC Analyst are responsible for representative sampling according to recommended plan...