Current Good Manufacturing Practice (cGMP guidelines) requirements are set up by the Food and Drug Administration (FDA) and serve as the benchmark for testing the quality of drug products in order to ensure they comply with the minimum standards.
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How to Review GMP Documents Like a Pro
GMP in pharmaceuticals plays an important role in document maintenance, compliance and product quality. Pharmaceutical documents like batch manufacturer and covered SOP, validation reports, deviation logs and other documents must be reviewed properly and accurately. A single mistake in any document can lead to product lead recall deviation or risk to patient health.
Regulatory Expectations from Cleaning Validation
Cleaning validation is an integral part of the pharmaceutical manufacturing process. A piece of equipment itself can contaminate the product if it is not cleaned properly. Improperly cleaned manufacturing equipment is a major source of cross-contamination. Regulatory agencies are more concerned about the cross-contamination of penicillin with non-penicillin products.
FDA Expands Unannounced Inspections at Foreign Manufacturing Facilities
Recently US FDA announced the expansion of unannounced inspections of foreign manufacturing facilities that produce medicines and medical products and supply them in the United States. The aim of this decision is to align the foreign manufacturing facilities with the domestic ones.
The importance of FDA Form 483s and Warning Letters in Pharmaceuticals
Compliance with good manufacturing practices is not optional in the pharmaceutical industry but is essential for public health and sustainability of business. The US Food and Drug Administration uses two important tools to ensure GMP compliance — Form FDA 483 and Warning Letters.
Importance of Data Integrity for Pharmaceutical Regulatory Agencies
In the pharmaceutical industry, data is everything because data is a proof of work. Batch manufacturing records and raw data ensure that pharmaceutical products are safe, effective and of high quality. Data integrity is the assurance that data is complete, consistent and accurate. Regulatory agencies found that data integrity issues are the most critical concerns in pharmaceutical industry.
Data Falsification in Pharmaceutical Industry
Falsification of analytical and manufacturing data is not rare these days. You may think only one or two such cases are found yearly but studies show that about 50% of data and pharmaceuticals are unreliable. In most of the cases, even companies don’t know about this data fabrication. In most cases, it is done by the personnel due to over workload or sometimes they produce backdated records.
Regulatory Compliance: 8 Common Mistakes and How to Avoid Them
In the pharmaceutical industry, regulatory compliance is essential, not optional. Companies following regulatory guidelines not only protect customers' health but also gain the reputation and operational continuity of the company. Our study on FDA warning letters shows that more than half of warning letters are issued to pharmaceutical manufacturers due to compliance violations.
10 Step Guide to cGMP Certification
In the pharmaceutical industry, it is mandatory to get certified by regulatory agencies. GMP certification ensures the quality of pharmaceutical products. Compliance with regulatory requirements ensures the efficacy and safety of pharmaceutical products.
Self Inspection and Its Implementation in Pharmaceuticals
Self inspection is basically a very useful and powerful mechanism for detecting any shortcomings or faults operating within any system. It means one needs to redeem on their own policies and check for its conformity and compliance with the appropriate corrective measures. It is a sure-shot way to evaluate the whole operating system from every aspect to ensure and maintain the quality of products.…
Case Studies: Troubleshooting Purified Water System Failures
Purified water in the pharmaceutical industry is a critical component because it is used at various stages of pharmaceutical manufacturing. There are many cases of water system failure in pharmaceutical industries that can be a cause of quality-compromised products. In this article, we shall discuss two different case studies of water system failures in the pharmaceutical industry.
Importance of Data Integrity in Pharmaceuticals
These days, pharmaceuticals have started relying on computers and automated systems to a great extent, whether in terms of manufacturing, laboratory release testing or many other tasks involved. Due to this, a renewed focus has been brought to the concept of data integrity. It is the responsibility of the pharmaceutical industry to ensure the efficacy, quality and safety of drugs, and at the same…
5 Steps of FDA Approvals
Medicines are not food and those are taken by unhealthy individuals. Therefore, the safety and efficacy of the drug product are a primary requirement while producing the medicines. Drug approval by the FDA is a critical process and has to follow different steps before any drug product reaches to the market. The following steps are followed by any company to get approval from the FDA to produce an…
Requirements of FDA for Training in Pharmaceuticals
The FDA compels every drug or medical devices manufacturer to train every employee starting with the regulated procedures to the CFR requirements. The FDA GMP training requirements in pharmaceuticals are defined in 21 CFR 211.25 and have three key aspects.
Planning and Procedure followed During Regulatory Audits
Different types of inspections are conducted by Regulatory Agencies. Following are the various types of inspections conducted periodically by Regulatory Agencies.
1 Routine Inspection: Quality System Inspection
2. Pre-approval Inspection for Pre-market Approval (PMA): Country-specific inspections
3. Follow-up on a warning letter (Violation): Inspector will look for evidence of the company's comp…
1 Routine Inspection: Quality System Inspection
2. Pre-approval Inspection for Pre-market Approval (PMA): Country-specific inspections
3. Follow-up on a warning letter (Violation): Inspector will look for evidence of the company's comp…
