Mechanical Integrity

Pharmaceutical and biotech production facilities, and the processing equipment are aging, with many systems aging beyond 20 years. Manufacturers are now beginning to experience problems associated with aging, and are having to develop strategies to respond to the approaching equipment end of lifetime. Traditionally, manual inspections are used to detect …

Data Integrity

Data integrity within a CGMP environment is defined as “the assurance that data records are accurate, completed, intact, and maintained within their original context, including their relationship to other data records”. This requirement applies to paper, electronic, and hybrids of both electronic and paper records to ensure that data is …