Tag: QA SOPs

Cleaning Validation SOP is for collecting samples for cleaning sample from equipment and machines for Cleaning validation SOP. Cleaning Validation SOP Importance: Cleaning Validation SOP have it own importance for the maintenance cleaning of equipment and machines, which provide us Quality products. 1. PURPOSE Main objective of the Cleaning Validation SOP is as following: 1.1 Describe a procedure for collecting samples for cleaning validation from different equipments / machines used in manufacturing to identify the traces of previous product that may contaminate the batch of subsequent product. 1.2 Eliminate chances of contamination or cross contamination of subsequent product manufactured. 1.3 Validate the procedures used for cleaning of equipments / machines used in manufacturing...

Management Review meeting SOPs in Pharmaceuticals is prepare for future planning and GMP review.  Management Review meeting is done between responsible for responsible staff. Management Review Meeting Management Review meeting is a formal, organized meeting that involves long-term management and takes place at regular intervals throughout the year. The purpose of a management review meeting is to evaluate and evaluate the effectiveness of your management system to help you determine your ongoing suitability and suitability. 1. PURPOSE To coordinate and control the activities of the current Good Manufacturing Practices (cGMP) being carried out by different departments in the company and to review the performance of the cGMP. 2. SCOPE This SOP covers all information related to cGMP...

Annual Product Reviews are created by all departments of the Pharmaceuticals Industry. Because Annual Product Reviews SOP reviews of products in all departments.   PURPOSE To outline a procedure that Provides instructions for Annual Product Reviews (APRs) of all marketed products of Pharmaceuticals. Includes a collection of data, evaluation of data & review of data by Technical Team. SCOPE This SOP applies to all departments through which products are manufactured, packed, inspected and tested during a year i.e. from January - December time period. All batches finally closed in this duration are included in Annual Product Reviews.  RESPONSIBILITY Quality Assurance Department. Enter the relevant data timely at respective...

The cGMP Self Inspections itself is performed in pharmaceutical production facilities in order to control the implementation of cGMP and the production process of the product. cGMP Self Inspections cGMP Self Inspections checklist plays an important role in self-control. cGMP Self Inspections is first and foremost a useful and powerful mechanism for identifying any deficiencies or errors operating in any system. That means one they should apply and monitor their own policies, if consistent, and take appropriate corrective action. It's a guaranteed way evaluate the entire operating system in all aspects to ensure and maintain product quality. cGMP Self Inspections is not limited to finding mistakes and foolishness, and infiltrators within the system, but also to find and plan ways to eff...

Control Of Non Conforming Products SOP is created for rejected material treatment, what should we do for rejected material in Pharmaceuticals. Control Of Non Conforming Products SOP In Pharmaceuticals Industry there is a proper way to dispose of every type of rejected material by a different way. In this SOP we also study this how pharmaceutical industries should dispose-off non-conforming products including Rejected materials according to guideline of WHO. 1. PURPOSE This SOP describes how to control, treat and dispose-off non-conforming products including Rejected materials. 2. SCOPE This SOP of Control Of Non-Conforming Products show controls all the steps taken in dealing with non-conforming products including reprocessing, rejected materials, Stability Study Batches and th...

In SOPs of Document and Data Control, we come to know how Pharmaceuticals industries are putting SOPs and Form number, which are used in a different parts of industries. Document and Data Control Importance Document and Data Control have significant importance in Pharmaceuticals because every document in the pharmaceuticals industry need a number which refer to the documents, that's why in every form, SOPs, log book or any other documents you will see the Document and Data Control listed number. PURPOSE To ensure that all documents are controlled and distributed so that only current issues are in use by those Employees requiring them. Documents are properly reviewed and approved prior to issue and changes to documents are properly authorized. To ensure that all documents will go th...

SOP on SOP in Pharmaceuticals for Formatting, Approval, Distribution & Retrival. This format is apply on all the Department SOP. SOP on SOP in Pharmaceuticals Sop on Sop is created by Quality Assurance Manager to improve the Quality of formating on Standard Operating Procedure and create a separate look in SOP. OBJECTIVE 1.1. The objective of this procedure is to lay down the procedure for the Preparation, Review, and Approval. Implementation, Distribution Retrieval and Control of Sop on Sop (Standard Operating Procedures). SCOPE 2.1. The procedure applies to all departments of ____Pharmaceuticals for the preparation of Sop on Sop and Forms. RESPONSIBILITIES 3.1. It is the responsibility of all ____Pharmaceuticals employees to follow this SOP as it is in written. 3.2. It i...

Pharmaceutical Product recall is defined as the removal of a product sold by the Company due to design or manufacturing defects that could compromise efficiency and safety. Product Recall Product purity or by government order. Withdrawal of a product from the market may begin if the product is suspected to be defective or is found to be defective on the basis of a market power study. complaints, assessment of the likelihood of danger or as prescribed by the FDA or the Authority the health / regulatory authorities (RAs) of the country where the product is sold. OBJECTIVE 1.1 The Objective of this SOP is to describe procedure for the product recall, responsibilities, actions its evaluation and to provide guidance on: 1.1.1 Circumstances under which a recall of product(s) is warrant...

Internal Audit in Pharmaceutical Industry is important to functional Quality Standards in every pharmaceutical production industry. When planning Internal Audit in Pharmaceutical Industry, the primary goal should be to keep in mind information collection and identification of all problem areas. Internal Audit in Pharmaceutical Industry SOP Internal Audit in Pharmaceutical Industry SOP is based upon standard FDA guidelines which are applied on every pharmaceuticals manufacturing industry. PURPOSE 1.1. To describe procedure for planning, execution, reporting and follow up of cGMP Internal Audit in Pharmaceutical Industry. SCOPE 2.1. This c.GMP audit procedure is applicable to all departments involved in Manufacturing, testing and storage of products. RESPONSIBILITIES 3.1. It is...