The Department of Quality Assurance ensures the quality of all products produced, at each stage of manufacturing or processing drug products.
Quality guarantee (QA) is a broad concept and includes all aspects that can have an impact on all quality measure pharmaceutical products. The purpose of QA is: to ensure that the drug determined competently provides the desired effect on the person who takes it.
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.
The purpose of this SOP is to set forth the procedure...
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 ...
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.
To control process variability
To operate the process smoothly
This procedure is to be followed while controlling process change in the production department.
Chief Executive Officer
Quality Control Manager
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...
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...
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....
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...
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.
To lay down the procedure to Pest and Rodent Control in Pharmaceuticals within the plant.
This SOP is applicable for pest & rodent control within the plant and the factory premises at pharmaceuticals.
QA Head shall be accountable for the implementation of th...
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.
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.
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.
This SOP covers all information related to cGMP...