FAQ's

Knors Pharma Solutions LLP is a pharmaceutical consulting company that provides professional services such as GMP audits, regulatory affairs consulting, gap analysis, due diligence, and training for pharmaceutical and biotechnology companies worldwide.

GMP audit consultants are experts who evaluate pharmaceutical manufacturing facilities to ensure compliance with Good Manufacturing Practice (GMP) guidelines. 

They provide independent inspections and compliance assessments, documentation review, and recommendations to improve pharmaceutical quality systems.

Pharma manufacturers, contract manufacturers, exporters, and healthcare companies frequently need third-party pharmaceutical audits.

Auditors review standard operating procedures, batch manufacturing records, validation reports, quality manuals and regulatory compliance documents. 

Knors Pharma offers a wide range of services including GMP audits, pharmaceutical consultancy, regulatory affairs support, GAP analysis, due diligence, and training programs on quality management systems.

The pharmaceutical industry, the biotechnology industry, the nutraceutical industry, the cosmetic industry and the healthcare product manufacturing industry all benefit from these services. 

Their assessment of manufacturing processes and quality systems, together with their evaluation of regulatory compliance, enables them to confirm safe product production and consistent product quality. 

They evaluate compliance with standards such as WHO-GMP, US-FDA, EU-GMP, and other regulatory guidelines. 

GMP audits occur annually or at times when regulatory authorities or quality management systems require them. 

The audit examines all aspects of manufacturing processes together with quality control systems, documentation procedures, hygiene protocols, equipment validation, and facility management systems. 

Auditors review standard operating procedures and batch records, training logs, validation protocols and calibration records and quality reports.

They make sure that drug companies follow the rules set by the government and keep their products safe and of high quality.

GMP audits help make sure that the rules are followed, the product is of higher quality, and the chance of making mistakes in production is lower.

They find problems in processes and suggest ways to fix them to make quality systems and manufacturing practices stronger.

Writing for CAPA means keeping track of the steps taken to fix quality problems and stop them from happening again.

A regulatory auditor checks pharmaceutical companies to make sure they follow both national and international rules and regulations.

Most of the time, you need a degree in pharmacy, life sciences, or quality management and experience with following the rules.

They do audits of their own work, audits of their suppliers, audits before inspections, audits of compliance, and audits of readiness for new rules.

GAP analysis is a way to find out how current practices differ from the rules that must be followed.

It finds areas where compliance is lacking, areas that need to be improved, and plans of action that need to be made to meet regulatory requirements.

Pharmaceutical companies should do GAP analysis on a regular basis, especially before big process changes or inspections by the government.