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Pharmaceutical Guidelines

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Regulatory Expectations for 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 abo…

Number of Temperature Probes for Autoclave Validation

Autoclave validation has a very important role in pharmaceutical sterile manufacturing and also in the microbiology laboratory. Whole sterile manufacturing process depends on proper sterilization of equipments used in manufacturing.

Less than 1 CFU/Plate in ISO 5 Class - How is it Possible?

There are different cleanliness classes in pharmaceuticals. Class 100 or ISO 5 is the highest cleanliness class found on pharmaceutical industries and used in LAF and sterile filling area. this area is monitored for viable and non-viable particle counts. Some people have confusions about the limits…

Criteria to Choose the Correct Swab for Cleaning Validation

In pharmaceutical manufacturing, the product must not be contaminated by previous product as well as it should not be contaminated with the cleaning agent used for equipment cleaning.

Good Clinical Practice (GCP)

Good Clinical Practice and reports are related to clinical trials. The biggest ethical factor with clinical trials is the fact that the research is conducted on human subjects. GCP is an international standard concerning clinical trials and their proper implementation. GCP defines all aspects of cl…

Working of an Effluent Treatment Plant

Water is an essential part of manufacturing industry processes and domestic use. Water is used as a coolant, solvent or in many other chemical based reactions in companies.
After the manufacturing process is completed, wastewater is produced as a byproduct. This wastewater is then called effluent. …

Data Integrity Survey Results

We had conducted a data integrity survey that has amazing results. 3360 visitors of participated in this data integrity survey and 87 % of them were from India. There were 8 simple questions regarding data integrity. Questions had options to select and all were mandatory to answ…

Quality System in Pharmaceuticals

Quality System in Pharmaceuticals or other words quality assurance is a dynamic process of understanding the regulations in this industry. The drugs that are taken to the consumers need to be safe and not cause long term effects on the one taking them.

Gap Analysis for Regulatory Compliance

If you are preparing for any regulatory inspection then gap analysis can help in compliance with regulatory guidelines. A comparison between the regulatory guidance and current practices is known as gap analysis.

Why Cold Chain Logistics are Required in Pharmaceuticals?

Over the years the pharmaceutical industry has used non-temperature specific drugs as pills for most of its purposes. Cold chain pharmaceutical logistics, however, for much of the decades, has been associated heavily with the food industry and less with the pharmaceutics. The introduction of new ty…

Quality Inspection in Pharmaceuticals

In pharmaceuticals, quality inspection involves a complete assessment and testing of medicinal products to ensure that they meet the required standards. It involves a number of actions taken place as discussed here.

Principles of Data Integrity

Data integrity is highly important in any industry, but especially so in the pharmaceutical industry where any data error could mean serious consequences. Data integrity is defined as maintenance and assurance of data consistency and accuracy throughout its life-cycle. Keeping data consistent (unch…

Common Technical Document (CTD) for Dossiers

Common Technical Documents or CTDs are critical sets of information of a new drug that comprise the application dossier. The application dossier is then submitted for the purpose of obtaining approval by regional regulatory authorities before the drug can undergo clinical trials and subsequently be…

How to Care for pH Meter Electrodes

pH meter electrodes measure the degree of acidity by comparing the aqueous solutions. The electrodes are immersed in with the reference half-cells built inside the electrodes. These half-cells are coated with silver chloride or AgCl.

Role of Regulatory Affairs in Pharmaceuticals

Regulatory affairs in pharmaceuticals are like vehicle inspectors in the automotive industry. They assess and perform quality checks to ensure that the medicinal drugs, veterinary drugs, and nutritional supplements rolled out by the pharmaceutical industry are safe and effective for the consumers t…

About the Author

Ankur Choudhary is experienced in pharmaceutical, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008.

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