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decreasing the frequency of audits when making the audit report available to pharmaceutical companies.

standardised GMP audits of API manufacturers.

The aims of The "APIC Audit Programme" are: The audits are conducted on the basis of the EC GMP Guide Part II/ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) with regard to the APIC Auditing Guide.

who have signed a contract laying down the obligations as an auditor in the framework of the APIC Audit Programme.

who have participated in recognised training courses/conferences on current GMP topics.

who have completed an ICH Q7 compliance education course including an examination and a special APIC Auditor Training.

The audits are conducted by APIC certified auditors

release of audit report by experienced API specialists.

standardised process for preparing audits.

experienced and trained auditors that are registered as APIC certified auditors.

There are three basic principles of the "APIC Audit Programme" for standardizing audits: *The costs for travel and accommodation as well as for the audit report will be charged additionally.

Frequently asked questions and answers regarding the Third Party Audit programme can be found here. The participation in the "APIC Audit Programme" is on a voluntary basis and not limited to members of APIC. Mock Inspection/Audit: An API manufacturer wants to know if the company meets the ICH Q7 requirements. Shared Audit: Several customers (manufacturers of medicinal products) want to audit the manufacturing site of their API supplier. Third Party Audit: A single customer (manufacturer of medicinal products) wants to audit the manufacturing site of his API supplier. Read more here about the APIC Audit Programme - APIC Audit Step by Step It can also be initiated by an API manufacturer himself. when preparing for authority inspections.

It is the aim of the APIC Audit Programme to offer an independent and 'turnkey' GMP Compliance audit of API manufacturers and/or distributors, including organizing, conducting and evaluating the audit.Īn 'APIC Audit' within the framework of the APIC Audit Programme can be initiated by one or more QPs from one or different manufacturing authorisation holders in order to get independent information about the GMP compliance status about the API supplier, e.g. The "APIC Audit Programme" is a third party audit programme for auditing API manufacturers, distributors and API contract manufacturers and/or contract laboratories. Immediately following the Offer to Amend and Exercise (after the effect of certain cash and cashless exercises), the Company issued in exchange for the warrants 29,666,782 common shares.APIC Audit Programme What Is the "APIC Audit Programme?" Prior to the Offer to Amend and Exercise, the Company had 58,159,495 shares of common stock outstanding and warrants to purchase an aggregate of 40,255,234 shares of common stock. The gross cash proceeds from such exercises were approximately $ 13.5 million and the net cash proceeds after deducting warrant solicitation agent fees and other estimated offering expenses were approximately $ 12.7 million. Pursuant to the Offer to Amend and Exercise, an aggregate of 30,966,350 Warrants were tendered by their holders and were amended and exercised in connection therewith for an aggregate exercise price of approximately $ 15.5 million, including the following: 3,750,000 Formation Warrants 754,000 Merger Warrants 7,243,750 2013 Investor Warrants 500,000 Private Placement Warrants 14,750,831 2015 Investor Warrants 722,925 $ 2.00 Placement Agent (PA) Warrants (of which 721,987 were exercised on a cashless basis) 1,426,687 $ 1.00 PA Warrants (of which 1,424,812 were exercised on a cashless basis) and 1,818,157 $ 0.75 PA Warrants (of which 1,774,017 were exercised on a cashless basis).