Natural Products Insider

SEP-OCT 2018

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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naturalproductsinsider . com 39 Contract Manufacturing: Audits environmental compliance and management implementation. A social audit is a way of measuring, understanding, reporting and ultimately improving an organization's social and ethical performance (e.g., child labor). Investigative or special audits are investigations of a specifi c area or individual when there is a suspicion of inappropriate or fraudulent activity. The intent is to locate and remedy control breaches, as well as to collect evidence in case charges are to be brought against someone. A special audit is a bit different from a forensic audit as the special audit is unusually done by internal staff of entity. For contract manufacturers, many of the above audit types apply. Auditor An auditor is an authorized individual who has been qualifi ed to conduct audits. An auditor may be either an internal auditor (an individual whose primary job function is to audit his or her own company) or an external auditor (an individual from outside the company, who typically is employed by an auditing fi rm who handles different clients). The auditor conducts methodical examination, inspection or review of a condition or situation to fi nd discrepancies. Many auditors specialize, depending on their background or experience. They can work as independent external auditors, internal auditors or governmental auditors. Auditors can also work for many different entities, such as a bank or a state government. GMP Audits It is primarily the GMP quality system audit that is of concern to dietary supplement manufacturers and sellers. GMP compliance audits are performed by FDA, third-party certifi ers and companies performing their own vendor audits. These are typically onsite manufacturing facility audits for compliance with both: 1 FDA GMPs (21 CFR part 111) and 2 any of the specifi c certifi er's requirements. Audit Steps & Process The fi rst step is to schedule a mutually workable date for the audit that suits both parties. Unlike regulatory audits, which are often unannounced, customer/vendor audits are typically scheduled. Audit preparation consists of everything that is done in advance by interested parties, to ensure the audit complies with the client's objective. Audit process, often called fi eldwork, is the onsite data-gathering activities portion of the audit and covers the time period from arrival at the audit location up to the exit meeting. Mainly, auditors look at both the facility and documentation, which is objective evidence. Always request to have an exit interview when the onsite audit is complete. Sometimes, any misunderstandings or missing information can be cleared up before the audit is formalized. The close-out meeting can also be the appropriate time to have a more detailed discussion about certain observations or discrepancies. The purpose of the audit report is to communicate the results of the audit. The report should factually show any Acid Resistant Vegetable Capsules ) ' u n . , u, ' . ' AN EXCELLENT CHOICE FOR DELIVERY OF ACID-SENSITIVE ACTIVE INGREDIENDTS . . . <> . BioCaps Enterprises, Inc. www.biocaps.net • info@biocaps.net US Patent 9452141 See us at SSW • Booth #1347 corrections, errors, gaps, inconsistencies, inadequacies, omissions, etc., that need to be addressed—or not. The report should provide correct and clear information that can be used as an effective management tool in addressing important organizational issues. The audit report usually requires a response regarding corrections or documentation of any defi ciencies reported. After receiving an audit report, the contract manufacturer must follow up and respond in a timely manner to any changes, corrections or documentation requested. When the responses are accepted, the audit is concluded. The purpose of an audit is to provide a report to the entity institution with the objective fi ndings of the audit (in relation to the audit criteria), as well as an assessment of the compliance and effectiveness of a company's operations. As a result of an audit, the various stakeholders may evaluate and improve the effectiveness of risk management, control and the governance process over the subject matter of what the audit covered. It can be an effective tool in the management toolbox for gauging and improving operations within a company. Robin C. Koon is executive vice president at Best Formulations (bestformulations.com). He has more than 35 years of pharmaceutical experience in a clinical pharmacy practice, retail drug chain operations and managed care, as well as nutraceutical/pharmaceutical manufacturing.

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