Why the alignment of audit scope with the correct industry standard is important
Pharmaceutical supply chains are typically vast and complex, often covering multiple geographical regions and involving a diverse set of suppliers, service providers and subcontractors.
To maintain a constant focus on quality across the supply chain network, it is common practice for a pharma company to commission external, independent audit partners to conduct audits of suppliers, subcontractors, or service providers. The key objective of this auditing activity will be to evaluate the conformity of processes and documentation against the most relevant industry standard and determine those regulatory requirements have been met.
The choice of the appropriate audit standard is essential for the good execution of the audit and its outcome. It is unlikely that the supplier will agree to implement corrective actions if they are not legitimate for their organisation. The choice of an inappropriate standard can also lead to an inappropriate conclusion. For example, if the outcome states that the compliance is not satisfactory against an audit standard that is not in-fact relevant, then the audit outcome is not useful or representative.
Take for example suppliers of excipients – these are controlled based on the results of a formalised quality risk assessment for ascertaining the appropriate Good Manufacturing Practice for excipients of medicinal products for human use and in most cases, the IPEC guide is the appropriate audit standard to use. APIs suppliers, however, must comply to EU GMP part II in Europe and are audited against this standard.
All part of the supply chain is important. Another example involves suppliers of packaging materials. For primary and secondary packaging ISO standards combined with quality agreements can be used as a quality standard for an audit including ISO 15378 for suppliers of primary packaging materials and ISO 9001 for suppliers of secondary or tertiary packaging materials. Other standards are relevant to contract laboratories, finished product manufacturers, distribution partners and IT service providers.
Driving Continuous Improvement
Alignment of a pharmaceutical audit scope with the most relevant pharmaceutical industry standard is key to optimising audit insights and help maintaining compliance. We know this will ultimately drive effective continuous improvement and help prevent quality failures in the future. An optimised audit helps to build the mutual confidence between supplier and a pharmaceutical organisation where the relationship is supported by an objective assessment of compliance.
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