Aug 12, 2025
HVAC System Validation in Pharmaceuticals | A Complete Guide to Compliance and Best Practices
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In pharmaceutical manufacturing, HVAC system plays an important role in maintaining controlled environmental conditions that are necessary f...
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Aug 11, 2025
Deviation Control in Pharmaceuticals | Steps, Documentation, and GMP Compliance
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Maintaining product quality and ensuring patient safety are the most important tasks in pharmaceutical industry. Unplanned events are one of...
Aug 4, 2025
Change Control in Pharmaceuticals | Process, Documentation, and GMP Compliance Guide
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Changes are always made in industries but in pharmaceutical manufacturing changes must be planned, documented, justified and approved. Any m...
Aug 2, 2025
Current Good Manufacturing Practices - cGMP in Pharmaceutical Industries
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Current Good Manufacturing Practice (cGMP guidelines) requirements are set up by the Food and Drug Administration (FDA) and serve as the ben...
Jul 31, 2025
How to Review GMP Documents Like a Pro
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GMP in pharmaceuticals plays an important role in document maintenance, compliance and product quality. Pharmaceutical documents like batch ...
Jul 24, 2025
EMA vs FDA Expectations on Process Validation
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In pharmaceutical manufacturing validation of manufacturing process ensures that the manufacturing process is consistent and producing a pro...
Jul 21, 2025
Regulatory Expectations from Cleaning Validation
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Cleaning validation is an integral part of the pharmaceutical manufacturing process. A piece of equipment itself can contaminate the product...
Jul 15, 2025
Computerized System Validation Planning and Execution
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Computer validation planning consists of a Computer Validation Plan (approach), specific activities required to carry out the plan, and a Co...
Jun 1, 2025
Basics of Cleaning Validation
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Cleaning of pharmaceutical instruments after a product has been manufactured is critical to ensure that the subsequent products to be manufa...
May 29, 2025
Understanding the US FDA Drug Approval Process
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It is a multi-step journey to ensure safety, efficacy and quality to bring a new drug in the market in the United States. This journal is co...
May 23, 2025
How to Submit a DMF (Drug Master File)
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During document submission to regulatory agencies, the Drug Master File (DMF) plays an important role in pharmaceuticals in protecting confi...
May 22, 2025
FDA Expands Unannounced Inspections at Foreign Manufacturing Facilities
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Recently US FDA announced the expansion of unannounced inspections of foreign manufacturing facilities that produce medicines and medical pr...
May 21, 2025
CAPA Documentation: Common Mistakes to Avoid
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Corrective and preventive action (CAPA) is an essential aspect of the pharmaceutical industry's quality system required by agencies such...
May 20, 2025
Top 4 Problems in Sterile Pharmaceutical Manufacturing
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Sterile pharmaceutical manufacturing is the most demanding area in pharmaceutical industry. Injectable drug products and other formulations ...
May 17, 2025
Gemba Walks and Its implementation in Pharmaceuticals
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Compliance quality and efficacy are non-negotiable in pharmaceutical industry. It is required to implement management practices to improve c...
May 14, 2025
Effective Deviation Management in Pharmaceutical Manufacturing
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Deviations in pharmaceutical manufacturing are not only manufacturing mistakes but they are threats to product quality, patient safety and r...
May 9, 2025
Cleaning Validation of Clean-in-Place (CIP) Systems
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Cleaning of manufacturing equipment has great importance in the pharmaceutical and biotechnology industries. It is required to clean manufac...
May 7, 2025
How to Strengthen Microbiological Control of Non-Sterile Pharmaceuticals
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Microbiological quality of pharmaceutical products is essential for patient safety and product stability. As we know, the sterile products a...
May 3, 2025
The importance of FDA Form 483s and Warning Letters in Pharmaceuticals
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Compliance with good manufacturing practices is not optional in the pharmaceutical industry but is essential for public health and sustainab...
Apr 30, 2025
Importance of Data Integrity for Pharmaceutical Regulatory Agencies
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In the pharmaceutical industry, data is everything because data is a proof of work. Batch manufacturing records and raw data ensure that pha...
Apr 28, 2025
Best Practices in Pharmaceutical Microbiology Laboratory
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Microbiology lab in the pharmaceutical industry helps to identify microbial contamination in pharmaceutical products. Critical analysis like...
Apr 26, 2025
Sterile Pharmaceutical Manufacturing Area (Cleanroom) Cleaning
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Injectable products like ophthalmic solutions, vaccines and injectable drugs are manufactured in sterile cleanroom areas. Cleanroom area mus...
Apr 25, 2025
Understanding the Stability of Injectable Products
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Stability of pharmaceutical products is important to make those stable, safe and effective for a long time. When it comes to antibiotics, va...
Apr 23, 2025
Usages of Artificial Intelligence (AI) in Pharmaceutical Industry
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Artificial intelligence is being used in every field these days. It has revolutionary effects on the pharmaceutical industry by speeding up ...
Apr 22, 2025
Data Falsification in Pharmaceutical Industry
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Falsification of analytical and manufacturing data is not rare these days. You may think only one or two such cases are found yearly but stu...
Apr 21, 2025
Extraneous Peaks in Chromatographic Analysis
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Chromatography is a popular analytical technique that separates compounds on the basis of their properties and how they interact with statio...
Apr 17, 2025
Principle and Working of Gas Chromatography
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Gas chromatography is one of the most useful analytical tools in pharmaceutical and chemical laboratories. Because of its reliability and ac...
Apr 16, 2025
10 Tips for Fresh Graduates Seeking Jobs in the Pharmaceutical Industry
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In the real world of pharmaceutical carriers, it is challenging to find a dream job after graduation. For many fresh candidates, a question ...
Apr 15, 2025
Regulatory Compliance: 8 Common Mistakes and How to Avoid Them
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In the pharmaceutical industry, regulatory compliance is essential, not optional. Companies following regulatory guidelines not only protect...
Apr 14, 2025
10 Step Guide to cGMP Certification
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In the pharmaceutical industry, it is mandatory to get certified by regulatory agencies. GMP certification ensures the quality of pharmaceut...