If you were the chief executive officer of a successful pharmaceutical company would you want to know that your company was meeting and exceeding customer expectations? Do you know who your customers are?
Your customers may be consumers of the product, patients and doctors, purchasers (managed care), shareholders, or regulatory authorities. In fact, your customers are all of these. Although their expectations will vary, the company has the common goal of fulfilling all their expectations. There are different ways to determine customer expectations, but without an adequate evaluations tool, a standardized comparison to a common reference point cannot be made.Current regulations for medical devices (21CFR 820) and good laboratory practices (21 CFR 58 and 40 CFR 160) include requirements for formalized and well-established and, maintained internal auditing programs. Current expectations of most other FDA-regulated industries, such as biotechnology and pharmaceuticals, are no different, although the regulations do not specifically mandate the installation of an internal auditing program. It is only a matter of time before these requirements are more clearly defined and codified in these and other areas.
Traditional GMP Audits by the compliance unit conclude with the issuance of observations. The observation responses are evaluated for acceptability and the file is closed. The time to eliminate the stigma surrounding Internal GMP Audits has arrived. Historically, Internal GMP Audits have carried a very negative connotation because of the adversarial manner in which they have typically been performed. Changing the objective of GMP Auditing from identifying deficiencies to assessing and enhancing quality would go a long way in shifting the perspective most companies have of Internal GMP Audit programs. GMP Audits should be viewed as an assessment of compliance to regulatory requirements and as one facet of overall quality.
The reasons for instituting an Internal GMP Audit program include the following:
- Increase the potential for early identification of regulatory concerns based on FDA interpretations and current compliance focus
- Identify compliance deficiencies and deviations from industry standards and company requirements
- Provide a benchmark of compliance with other companies and regulatory expectations.
- Inform management of compliance status, regulatory risk, and civil liability
- Foster continuous improvement and forward quality
- Provide a tool by which the company can stay ahead of rapidly increasing regulatory demands
Essential requirements for a successful Internal quality/compliance GMP Audit program are as follows:
- Executive management total commitment to Quality and the GMP Audit program
- An adequate number of qualified personnel well-suited to conduct Internal Quality and GMP Compliance Audits
- Established standards against which to Audit
- An independent reporting structure directly responsible to executive management with the authority to allocate resources
- The resources (economic, personnel, time) to support the program’s and operation’s ongoing needs