Pharmaceutical cleanroom areas are used to protect pharmaceutical products from pollutants that cause undesired contamination in pharmaceutical products to be produced. These contaminants can occur due to several reasons. Human being plays a significant role in producing this contamination through …
6 Ways to Reduce Human Errors in Pharmaceuticals
Human errors have critical effects on pharmaceutical product quality. About 80% of the product quality issues occur due to the human errors. Human errors are traced by the occurrence of the deviations in the process. Most of the root causes of deviations are human errors due to improper communicat…
Critical Mistakes during Root Cause Investigation
Root cause analysis is a very frequently used tool in pharmaceutical industries to identify the cause of any deviation and determine the CAPA for GMP violations. Improper root cause investigation is commonly found in observations of regulatory inspections.
Fault Tree Analysis for Investigation
The fault tree is an investigation tool to identify and resolve the defects in any system or process. It is also helpful to find the root cause of any event. An organization or company may have more than one fault trees based on their defects, errors or problems.
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. …
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 pharmaguideline.com 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.
