Making GMP training relevant

Good Manufacturing Practice (GMP) GMP is a system that ensures consistent production of high quality products. GMP processes at each stage of production aids in maintaining the quality of every finished batch and helps eliminate errors that cannot be rectified in a finished product.1,2 Most countries have developed GMPs by adapting GMP guidelines laid down

Read More

FDA’s New Social Media Policy

The social media policy of FDA applies to all employees and contractors of the drug administration. The policy outlines expectations and guidelines to encourage healthy use of technologies that support FDA’s communication and exchange of credible information with the primary interest of protecting and promoting public health. Definition and scope of the policy FDA defines

Read More

Pharmacovigilance

What is pharmacovigilance? Pharmacovigilance is a branch in clinical research that involves all activities related to drug surveillance to track, detect, and assess adverse events and possible idiosyncrasies related to the drug. In response to the thalidomide tragedy in 1961, the WHO promoted global pharmacovigilance programs to ensure patient care and safety.1 The WHO program

Read More

THE 10 PHASES OF AN EFFECTIVE CAPA

The U.S. Food and Drug Administration, as well as other regulatory agencies view Corrective and Preventive Action (CAPA) as the central component that influences all control segments.  This includes design, production and process controls. It also encompasses documents change controls, material controls, facility and equipment controls. The worst thing that can happen is a sudden

Read More

MANAGING QUALITY CONTROL LABORATORY RECORDS

What is Laboratory Quality? Laboratory quality can be defined as accuracy, reliability, and timeliness of reported test results. Every Laboratory should have standardized forms to support the Laboratory Quality system. Once  the  forms are used to record information, they become records. What are Records? Records are the proof of the Laboratory quality and they must

Read More

Writing Effective Deviation Investigations

Deviation investigations are a very common topic to be reviewed during FDA investigations.  Ensuring the firm has robust and complete write-ups of these situations is key to a successful audit.  Having inadequate investigations could potentially cause some severe issues for the company and may sometimes result in warning letters, consent decrees or recalls. Proper root

Read More

An Introduction To Analytical Instrument Qualification & Validation — Meeting FDA Expectations

According to the FDA and other regulatory agencies, analytical instruments should be under the same strict control as manufacturing equipment. Analytical instruments provide critical scientific data about a manufactured product. This data ensures confidence that a quality product has been manufactured and is appropriate and safe for sale to the public. Therefore, as manufacturers, we

Read More

How To Make Sure Your Foreign Vendors Are FDA Compliant — And Stay That Way

Vendor selection is a serious process. Manufacturers are responsible for compliance from their selected vendors, and any violations by vendors can cause serious problems for the manufacturers. Choosing a foreign vendor is no different than choosing a domestic vendor; foreign vendors are held to the same FDA standards as domestic vendors. Manufacturers must have assurance

Read More