Quality Assurance - Pharma Egg

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. ...

Mar62023 by KBS.No Comments

SOP for Preparation of Batch Manufacturing Record (BMR)

Quality Assurance, General Topics, SOPs

A batch Manufacturing Record (BMR) is a document that contains all the necessary information related to the manufacturing process of a specific batch of a product. The SOP for Preparation of Batch Manufacturing Record (BMR) is a critical document that provides a comprehensive and detailed account of the manufacturing process and is used to ensure that the batch is manufactured in accordance with established procedures and specifications. Overall, the BMR should be a complete and accurate record of the manufacturing process for a specific batch of a product. It should provide all the information necessary to ensure that the batch is manufactured in accordance with established procedures and meets the required quality standards. PURPOSE The purpose of this SOP is to set forth the procedure...

Mar32023 by XhaamiNo Comments

Relative Humidity vs Absolute humidity vs Specific humidity

SOPs, General Topics, Production, Quality Assurance

Relative humidity, absolute humidity, and specific humidity are three important atmospheric parameters that describe the amount of moisture in the air. Relative Humidity vs Absolute humidity vs Specific humidity Although all three are related to the moisture content of air, they each measure different aspects of it. Relative humidity refers to the amount of water vapor in the air compared to the amount of water vapor the air can hold at a given temperature. It is expressed as a percentage, with 100% relative humidity meaning that the air is saturated and can no longer hold any additional moisture. Absolute humidity refers to the actual amount of water vapor present in the air, measured in units such as grams per cubic meter (g/m3) or grains per cubic foot (gr/ft3). Absolute humidity ...

Feb232023 by KBS.No Comments

SOP for Procedure for Process Change Control

Quality Assurance, General Topics, SOPs

Process change control is a crucial part of pharmaceutical manufacturing operations as it ensures that any modifications made to the manufacturing process are evaluated and documented to ensure product quality, safety, and efficacy. SOP for Procedure for Process Change Control is essential to follow a well-defined change control process in the pharmaceutical industry to ensure that any modifications made to the manufacturing process are thoroughly evaluated, documented, and controlled to ensure product quality, safety, and efficacy. PURPOSE: To control process variability To operate the process smoothly SCOPE: This procedure is to be followed while controlling process change in the production department. RESPONSIBILITY: Chief Executive Officer Quality Control Manager Quali...

Feb82023 by KBS.No Comments

Standard Operating Procedure on Sop in a Pharmaceutical Industry

General Topics, Quality Assurance, Quality Control, SOPs

A Standard Operating Procedure on Sop in a Pharmaceutical Industry is a detailed, written instruction that outlines the steps required to perform a specific activity within a pharmaceutical industry. It provides a standard and consistent approach to processes, ensuring that they are performed accurately, consistently, and in compliance with regulatory requirements. In the pharmaceutical industry, SOPs are critical to ensure the quality and safety of drug products, as well as to ensure compliance with regulatory requirements. Each SOP should include a clear description of the steps involved, the personnel responsible for each step, and the equipment and materials required. It should also include clear instructions on how to perform each step, as well as on how to document and record t...

Feb82023 by KBS.No Comments

Risk Management in Pharmaceuticals

SOPs, General Topics, Quality Assurance, Quality Control

Risk management in pharmaceuticals is the systematic process of identifying, assessing, and prioritizing potential risks associated with the development, production, and distribution of drugs, and implementing measures to mitigate these risks. This involves identifying and assessing the potential risks associated with each stage of the drug development process, from the initial discovery and development of new compounds to the post-market monitoring of drugs once they are on the market. Risk mitigation strategies may include changes to the drug's formulation, manufacturing processes, labeling, or distribution methods, as well as increased monitoring and clinical testing. The goal of risk management in pharmaceuticals is to ensure that drugs are safe and effective for patients, while also b...

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 KIRRANo 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...