How do you build the quality that is essential to all processes and products? Training auditors to conduct good audits is one way. These are some critical skills auditors must know to conduct successful audits:
Using audit trails and checklists to prepare and conduct audits
Knowing what points are often missed during an inspection
Effectively evaluating audit and report findings
Identifying critical components for a good audit report
Understanding the concepts behind compliance auditing while knowing global cGMP concepts and regulatory requirements related to auditing
Tools such as checklists also can help the auditor focus on key items. With proper training, auditors can find issues early, when they may be more easily corrected—and long before they become unmanageable or systemic. ISPE has a popular course to provide this training, called GMP Auditing for the Pharmaceutical Industry.
Pharmaceutical manufacturing sites that export their products around the world are often subjected to many GMP inspections each year by different regulatory authorities, with a significant number of these being duplicate, same-scope inspections. This is...
Asia Pacific Pharma Outlook
The healthcare market in the Asia Pacific (APAC) region is continuing to grow at a steady rate with an estimated 500-billion-dollar industry by 2020. This is due to rising development in smart manufacturing and government...