Malawer & Associates Consulting, LLC
Pharmaceutical, Chemical, & Dietary Supplement Value Creation
Supplier Auditing
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"Dr. Malawer came very highly recommended (by a colleague who I hold in very high regard) to help our company implement a CMO audit program. I can say with confidence that Ed is an extremely competent, professional and ethical quality systems auditor who met or exceeded the very high standards our company expects. He is very knowledgeable in drug cGMPs and cGLPs and as a result has protected our company by assuring a high degree of compliance of our CMOs. Ed produced very comprehensive and detailed audit reports that we have been able to use as reference documents. Ed has also adapted well to our company culture without compromising his own values and ethics."
Larry Freedman
Director of Technical Operations
Insight Pharmaceuticals, LLC
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Malawer & Associates Consulting provides expert 3rd party auditing services to small to medium size drug product and drug product ingredient firms lacking internal, qualified auditors or needing to augment the existing auditing staff. Our firm specializes in initial and regular cGMP qualification audits of ingredient suppliers and contract manufacturing (tolling) operations (CMOs).
We create value for our clients by providing a critical element of the cGMP drug product quality management system at a reasonable cost avoiding the need to add to headcount. Our aims are to ensure compliance to federal regulations and to protect our clients from FDA inspection 483 findings, warning letters, consent decrees, seizures and fines.
We perform 1 to 3 day on-site drug product audits of the key operations and documentation of clients’ suppliers according to the 21 CFR part 211 regulations. We employ a very comprehensive questionnaire and produce highly detailed audit reports with completed corrective action request forms, as needed. Our firm is also able to discharge food ingredient and dietary (nutritional) supplement ingredient supplier audits under 21 CFR part 110 and 21 CFR part 111 regulations, respectively.
Note: A sample, highly-redacted audit report is available for review by interested prospective clients. Please contact our firm directly via telephone or email to request a copy.
Pharmaceutical cGMP regulations require that drug product firms qualify their suppliers and to monitor and control incoming raw material ingredients as well as CMOs performing contracted unit operations. For small drug product firms, this is best handled through independent, 3rd party audits since this avoids any conflicts of interest which can arise when operations managers also perform a quality assurance auditing function.
Question:
Why should a small to medium size pharmaceutical product company select Malawer & Associates Consulting, LLC as its preferred provider of 3rd party ingredient supplier and CMO auditing services?
Answers:
1) Knowledge and training: Dr. Malawer is highly qualified having been the vice president and chief quality officer of a major pharmaceutical excipient supplier, International Specialty Products, where he instituted a comprehensive auditing system consistent with the higher GMP requirements for API production. He has received formal cGMP drug product training through ISPE (the GMP Institute) and has been awarded the Certified Quality Auditor credential from the American Society for Quality.
2) Ethics and professionalism: Dr. Malawer has an excellent reputation in the pharmaceutical and chemical industries for highly ethical standards as well as thoroughness and attention to detail. The audit reports he generates are extremely comprehensive. Dr. Malawer assures that excellent and productive working relationships are maintained between the client, the auditee staff, and the auditors throughout the entire audit process. The USP's Verification Programs Department has engaged Dr. Malawer as a lead auditor of participating excipient and dietary supplement firms since 2009.
3) Flexibility: We attune the timing of the audit and the entire audit process as much as possible to the requirements of the client (within the confines of the regulations). Our firm understands that small pharmaceutical firms must be able to operate in a flexible manner in order to remain solvent in the current business environment. We do not use a "cookie cutter" approach to supplier auditing. We pride ourselves on serving the auditing needs of our clients in the time-frames they require. Workload overflows are handled with a cadre of highly qualified associate auditors.
4) Value: The audit services we supply are offered at very fair pricing given the level of effort required to produce our very comprehensive cGMP audit reports. The end result is a high degree of compliance protection for the client firms. Audits prices are based upon the number of man-days on-site, one, two, or three. The fixed price includes audit preparation, travel time to and from the audit site, conducting the audit, creation of the final audit report with incorporation of client corrections, and generation of corrective action request (CAR) forms for all major audit citations. (Reasonable, direct travel costs are billed additionally.)
We create value for our clients by providing a critical element of the cGMP drug product quality management system at a reasonable cost avoiding the need to add to headcount. Our aims are to ensure compliance to federal regulations and to protect our clients from FDA inspection 483 findings, warning letters, consent decrees, seizures and fines.
We perform 1 to 3 day on-site drug product audits of the key operations and documentation of clients’ suppliers according to the 21 CFR part 211 regulations. We employ a very comprehensive questionnaire and produce highly detailed audit reports with completed corrective action request forms, as needed. Our firm is also able to discharge food ingredient and dietary (nutritional) supplement ingredient supplier audits under 21 CFR part 110 and 21 CFR part 111 regulations, respectively.
Note: A sample, highly-redacted audit report is available for review by interested prospective clients. Please contact our firm directly via telephone or email to request a copy.
Pharmaceutical cGMP regulations require that drug product firms qualify their suppliers and to monitor and control incoming raw material ingredients as well as CMOs performing contracted unit operations. For small drug product firms, this is best handled through independent, 3rd party audits since this avoids any conflicts of interest which can arise when operations managers also perform a quality assurance auditing function.
Question:
Why should a small to medium size pharmaceutical product company select Malawer & Associates Consulting, LLC as its preferred provider of 3rd party ingredient supplier and CMO auditing services?
Answers:
1) Knowledge and training: Dr. Malawer is highly qualified having been the vice president and chief quality officer of a major pharmaceutical excipient supplier, International Specialty Products, where he instituted a comprehensive auditing system consistent with the higher GMP requirements for API production. He has received formal cGMP drug product training through ISPE (the GMP Institute) and has been awarded the Certified Quality Auditor credential from the American Society for Quality.
2) Ethics and professionalism: Dr. Malawer has an excellent reputation in the pharmaceutical and chemical industries for highly ethical standards as well as thoroughness and attention to detail. The audit reports he generates are extremely comprehensive. Dr. Malawer assures that excellent and productive working relationships are maintained between the client, the auditee staff, and the auditors throughout the entire audit process. The USP's Verification Programs Department has engaged Dr. Malawer as a lead auditor of participating excipient and dietary supplement firms since 2009.
3) Flexibility: We attune the timing of the audit and the entire audit process as much as possible to the requirements of the client (within the confines of the regulations). Our firm understands that small pharmaceutical firms must be able to operate in a flexible manner in order to remain solvent in the current business environment. We do not use a "cookie cutter" approach to supplier auditing. We pride ourselves on serving the auditing needs of our clients in the time-frames they require. Workload overflows are handled with a cadre of highly qualified associate auditors.
4) Value: The audit services we supply are offered at very fair pricing given the level of effort required to produce our very comprehensive cGMP audit reports. The end result is a high degree of compliance protection for the client firms. Audits prices are based upon the number of man-days on-site, one, two, or three. The fixed price includes audit preparation, travel time to and from the audit site, conducting the audit, creation of the final audit report with incorporation of client corrections, and generation of corrective action request (CAR) forms for all major audit citations. (Reasonable, direct travel costs are billed additionally.)
