Validation processes produce some of the key GMP evidence in a pharmaceutical plant. Qualification procedures, performed reports, raw data, calibration documentation, electronic documents, audit trails, calculations, deviations and approvals all together provide information on whether pieces of equipment, systems, procedures or their methods work properly.
Showing posts with label Data Integrity. Show all posts
Validation of Electronic Logbooks in Pharmaceutical Manufacturing
Because of the need to enhance efficiency and to minimize data errors and strengthen data integrity, the pharmaceutical sector is currently making the transition from paper-based records to e-systems. This trend is exemplified by the fact that more and more equipment operation logs, cleaning practices records, calibration logs, maintenance records, environmental and utility operation records are…
Data Integrity Challenges in Validation Activities in Pharmaceuticals
Within the validation processes of the pharmaceutical industry, a considerable amount of data is created through activities such as equipment qualification, process validation and computerized system validation. All validation activities must have access to accurate and reliable data; therefore, this data becomes a key component in making critical business decisions including but not limited to p…
Validation in Paperless and Digital Manufacturing Systems
The pharmaceutical sector is experiencing great change as it is evolving from an older, conventional method of manufacturing using paper means to a newer, modern method of manufacturing using digital or paperless means. This transformation is happening due to several reasons: improved efficiency, real-time access to data, improved compliance and reduction of errors caused by humans.
21 CFR Part 11 Requirements for Laboratories
In pharmaceutical laboratories electronic data systems have replaced paper documentation. Instruments like HPLC, GC, Spectrophotometer and stability chambers now generate electronic data that is processed digitally. This electronic system improved efficiency and traceability of the instruments and their data.
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.
Different Ways to Improve Pharmaceutical Productivity and Product Quality
Every business owner wants to produce more products to achieve the new milestones in manufacturing. The pharmaceutical field is different from the others in the quality of products. It is a great idea to scale up the production but at the same time, product quality must not be compromised. Following are some proven ways to improve productivity without compromising product quality.
Importance of Data Integrity in cGMP: Ensuring Drug Safety and Quality
In 2016 FDA published a guidance “Pharmaceutical Manufacturing/Quality Standards Data Integrity and Compliance with cGMP” to highlight the data integrity issues found during the FDA inspections in pharmaceutical companies. FDA emphasized data integrity and its importance to ensure the safety and quality of drugs to protect public health. Data integrity violations result in various regulatory acti…
