Shadow

Production

Manufacturing Facility in Pharmaceuticals Industry have different type & Section that we explain here

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  ...
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...
Laboratory Equipment Qualification Procedure SOP

Laboratory Equipment Qualification Procedure SOP

Quality Assurance, Production, Quality Control, SOPs
Laboratory Equipment Qualification Procedure SOP outlines the steps and processes for qualifying laboratory equipment to ensure its reliability, accuracy, and compliance with regulatory requirements. Below is a general template for such a procedure. Please note that specific details may need to be tailored based on the type of equipment and regulatory requirements applicable to your laboratory. PURPOSE To describe the procedure for defining the responsibilities, planning, protocol writing, performing the qualification activity, and subsequent record generation. The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for the qualification of laboratory equipment to ensure accurate and reliable results and compliance with regulatory requirements. SCO...
SOP for Managing the Product Recall Process

SOP for Managing the Product Recall Process

Quality Assurance, General Topics, Production, SOPs
SOP for Managing the Product Recall Process is crucial for organizations to manage and execute an efficient and effective recall process when necessary. This SOP should provide clear guidelines on how to identify, initiate, and execute a product recall to minimize risks to consumers and comply with regulatory requirements. OBJECTIVE The purpose of this Work Instruction is to describe the procedure for the management of the recall, or potential recall, of sales products from the marketplace. Clearly state the purpose of the SOP, which is to establish a systematic process for managing product recalls to ensure the safety of consumers, comply with regulatory requirements, and protect the reputation of the organization. SCOPE This Work Instruction applies to all products manufactured and m...
SOP for Manufacturing In process Control

SOP for Manufacturing In process Control

Quality Assurance, General Topics, Production, SOPs
SOP for Manufacturing In process Control for Manufacturing In-Process Control is essential to ensure the quality and consistency of products during the manufacturing process. These procedures help monitor and control critical parameters at various stages of production. Purpose To describe procedures for manufacturing in process control. Clearly state the purpose of the SOP, which is to establish guidelines and procedures for the implementation of in-process controls to monitor and maintain the quality of products during manufacturing. Scope This SOP applies to all in process manufacturing control. Define the scope of the SOP, specifying the manufacturing processes and stages where in-process controls are applicable. Responsibilities It is the responsibility of QAIP and Assistant ...
Standard operating procedure for Equipment Qualification

Standard operating procedure for Equipment Qualification

Quality Assurance, General Topics, Production, Quality Control, SOPs
Standard operating procedure for Equipment Qualification is a critical process in various industries, including pharmaceuticals, biotechnology, healthcare, and manufacturing. It ensures that equipment meets specified requirements and is suitable for its intended purpose. Standard Operating Procedures (SOPs) for equipment qualification help maintain consistency, reliability, and compliance with regulatory standards. Objective: Objective of this SOP is to address the guidelines for the execution of the Equipment Qualification i.e. (Installation Qualification (IQ)), (Operational Qualification (OQ)) and (Performance Qualification (PQ)). Clearly state the purpose of the SOP, which is to define the systematic process for qualifying equipment to ensure its reliability, accuracy, and compliance ...
Determining Shelf Life And Stability Testing Programme

Determining Shelf Life And Stability Testing Programme

Quality Assurance, General Topics, Product, Production, Quality Control, SOPs
Standard Operating Procedure for Determining Shelf Life And Stability Testing Programme Determining Shelf Life And Stability Testing Programme is the stability testing programmed for all pharmaceutical products manufactured at Company facility confirm the stability of the products and compatibility. PURPOSE To describe the stability testing programmed for all pharmaceutical products manufactured at Company facility. To confirm the stability of the products and compatibility with its container, while stored in accordance with labeling conditions and time, and with respect to product degradation. Pharmaceutical products will be tested at designated intervals for certain physical, chemical and microbiological properties. To collect scientific evidence based on test results to d...