A Drug master file is a submission form, that is required to submit to the Food and Drug Administration (FDA). A US DMF (Drug Master File) is a document that is submitted to regulatory agencies to provide confidential, detailed information about a drug API, drug product, or excipient. It is used to support the approval … Read more
Below learn about the List of Stamps, Colors and Types of Document Copies (Master, Controlled, and Obsolete Copy) and the difference between Controlled documents and uncontrolled Documents used in the Pharmaceutical documents system. Types of Document Copies in Pharmaceuticals: Master Documents: The originally approved copy of a document Is marked as a “MASTER COPY” stamp … Read more
Schedule M was incorporated by the Drug and cosmetic act of 1940 in 1988. Schedule M is also known for Good manufacturing practices. But earlier there were no rules and regulations that dictated us to know, How is our pharmaceutical building, location, premises, water system, construction area, warehouse, etc. Introduction to M Schedule Schedule M … Read more
Batch manufacturing records (BMR) are an essential part of pharmaceutical manufacturing as they document the entire process of production and ensure that all steps have been performed correctly. Here are the preparation steps for BMR as per schedule M in pharmaceuticals: Steps for Batch Manufacturing Records Preparations: 1. Design the BMR format: The BMR should … Read more
In Industries, we always face confusion about the “Usage of expired Raw Materials” and “Retesting of expired raw materials” in the formulation of finished drug products. in this article, We will cover some Questions about Expired Raw and API materials in warehousing, as we have tried to explain them in a simple way. What is … Read more
SAT is an inspection at the user’s site after machine/instrument delivery. opposite to SAT, the Factory acceptance test is a Manufacturer site inspection by the user. site acceptance test in pharmaceuticals is done to verify the functioning, operation, and parameters along with manufacturere repersentative. Site Acceptance Protocol Site acceptance test protocol is prepared by the … Read more
The airlocks is a transition space that typically has two doors in series to separate controlled environments such as a cleanroom, lab, operating room, or isolation room from the corridor. What is an airlock? Airlocks are commonly used in the pharmaceutical industry to maintain cleanliness and prevent contamination of the manufacturing environment. In a pharmaceutical … Read more
In today’s Pharmaceutical industries, the Granulation Technique is highly employed to get better Quality granules. Granulation is the act or process of forming or crystallizing into grains. Granules typically have a size range between 0.2 to 4.0 mm, depending on their subsequent use. Synonym “Agglomeration“: Agglomeration processes or, in a more general term, particle size … Read more
Air changes in pharmaceutical cleanrooms play a significant role in maintaining the cleanroom quality as per ISO CleanRoom Classification through the HVAC system. Air change per hour is the number of total replacements of any room air in one hour. if the supply of air by the HVAC system in one houres is equal to … Read more
Due to the growing demand for GMP and regulatory requirements in the pharmaceutical industry, there is a high chance of deviations occurring. These deviations must be documented, and the manufacturing organization recognizes the need for a standard operating procedure (SOP) for handling such deviations. However, even with good compliance practices in place, there may still … Read more
Change control is Managing to control a change in a process/procedure/system through proper and scientific justification, review, approval, implementation, follow-up, and closure. EU GMP Annex 15 Guidelines explain “change control” as: “The given statement describes a formal process in which qualified individuals from relevant fields review proposed or actual changes that could potentially affect the … Read more
Most pharmaceutical manufacturing companies have realized that in order to achieve the goal of long-term business survival in today’s regulated environment, they need to install a full eMES system, also known as the eBMR system. However, the current infrastructure situation prevents such an implementation from proceeding. Before discussing the difference between BMR/BPR and eBMR, it … Read more
Before beginning an on-site audit, the following Check List for Visitors points should be considered: Using the WHO-GMP Document Checklist can help you understand the requirements during visits to the premises. Document Check List for Visitors Format-B: Product summary sheet Conclusion: A Good Manufacturing Practice (GMP) audit checklist is one of the most effective methods … Read more
Six Sigma is an extremely disciplined activity that focuses on growing and giving close to excellent products and services. Six Sigma focuses on what’s necessary for the client. It reduces method variation defects, so nearly all the product or services provided meet client expectations. Six Sigma has been utilized by some of the world’s most … Read more
Good manufacturing practice and current good manufacturing practice are both terms correlated with each other. Both GMP and cGMP same purpose and functionality, They work together to achieve the quality, efficacy, and Productivity of a product’s goods. GMP and cGMP: GMP stands for good manufacturing practice, while cGMP stands for current good manufacturing practice. What … Read more
Recall and complaints both are different things that are used for marketed products. Recall means a company’s removal and correction of a marketed product that the FDA considers to be in violation of GMP. The Recall does not include market withdrawals. Whereas for product Complaints is not good things. It shows customer dissatisfaction with the manufacturer’s … Read more