Quality Assurance - Pharma Egg

Jan312023 by KBS.No Comments

Sampling and Testing of Packing Materials

Testing Methods, Production, Quality Assurance, Quality Control

The Sampling and Testing of Packing Materials should take account of at least the following: the quantity received, the quality required, the nature of the material (e.g. primary packaging materials and/or printed packaging materials), the production methods, and what is known of the Quality Assurance system of the Sampling and Testing of Packing Materials manufacturer based on audits. The number of samples taken should be determined statistically and specified in a sampling plan. Sampling and Testing of Packing Materials is an important operation in which only a small fraction of a batch is taken. Valid conclusions on the whole cannot be based on tests which have been carried out on non representative samples. Correct sampling is thus an essential part of a system of Quality Assurance....

Jan292023 by KBS.No Comments

Measuring and Monitoring of Noise Level

SOPs, Production, Quality Assurance

Measuring and Monitoring of Noise Level is a process to measure the magnitude of Noise in industries and residential area. Data collected from Noise level monitoring & Testing helps us to understand trends and action can be taken to reduce noise pollution. The Measuring and Monitoring of Noise Level of noise from a stationary source is carried out near the source where sound pressure is higher from the source compared to all other noise. The sound measured nearby the source tells the noise generated by the source. Sound level measured from specific distance from sound source can be used to calculate sound power output. Similarly, Measuring and Monitoring of Noise Level Sound power of the source can be used to calculate pressure level for the sound at other locations away from the...

Jan282023 by KBS.No Comments

Pest and Rodent Control in Pharmaceuticals

SOPs, Quality Assurance

Describes Pest and Rodent Control in Pharmaceuticals program including controls for rodents, insects, birds, pets etc. Criteria shall be describe how monitoring is conducted by the establishment or outside contractor. Also includes applicable pest control devices and their locations and chemical application. Only emulsifiable concentrate grade pesticides with known antidote shall be allows to use as per instructions mentioned in Agreement. OBJECTIVE: To lay down the procedure to Pest and Rodent Control in Pharmaceuticals within the plant. SCOPE: This SOP is applicable for pest & rodent control within the plant and the factory premises at pharmaceuticals. RESPONSIBILITY: QA Officer. Admin Officer. ACCOUNTABILITY: QA Head shall be accountable for the implementation of th...

Jan282022 by KBS.No Comments

Cleaning Validation SOP

Quality Assurance

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...

Jan282022 by KBS.No Comments

Management Review Meeting SOP

Quality Assurance

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...

Jan272022 by KBS.No Comments

Annual Product Reviews SOP

Quality Assurance

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...

Jan272022 by KBS.No Comments

cGMP Self Inspections SOP

Quality Assurance

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...

Jan272022 by KBS.No Comments

Control Of Non Conforming Products SOP 1

Quality Assurance

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...

Jan272022 by KBS.No Comments

Document and Data Control in Pharmaceuticals SOP

Quality Assurance

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...

Jan272022 by KBS.No Comments

Personnel Hygiene in Pharmaceuticals Industry SOPs

General Topics, Quality Assurance

Personnel Hygiene in Pharmaceuticals Industry SOPs is created to improve personnel hygiene of the employees that work in the Pharmaceuticals Industry. 1. PURPOSE To improve and maintain the conditions of personnel hygiene of the employees according to regulatory authority requirements and international standards. 2. SCOPE This SOP applies to all employees entering the manufacturing and warehouse areas of Pharmaceuticals. 3. RESPONSIBILITY 3.1 HR Manager is responsible for initial and ongoing health examination of the employees. 3.2 Administration staff monitors personnel hygiene standards of all employees entering in process area and ensures that overall working environment of the company shall be as per SOP. 3.3 Department head / Section in-charge ensures observance of per...