In today’s product safety issues audit management play a very important role responsible for ensuring quality and safety with an established internal/ external audit staff, audit programs, training the appropriate audit personnel. Companies are taking more organized approach for audit management both internal audits and external audits of supplies and outsourcing partners, GMP third party audits are used by many companies to reduce the costs related to the audit process and to save resource have increased significantly. This will reduce audit time and cost, improve product quality and safety, mitigate risk and improve on facility compliances for industry regulations.
The internal SOPs guided by GMP requirements, technology with a holistic end to end approach for API auditing process and meeting global standards are now become mandatory to meet up the expectation of updating new requirements now and then by EU GMP and FDA cGMP.
The integrated auditing capabilities are part of a larger quality management philosophy, with qualified team internally or external ie third party audits accepted by EU and USFDA regulators can be used to verify the compliances status of a vendor.
The audit should ensure follow-up on corrective and preventive actions, trending, good communication and scheduling between drug substance manufacturer and drug product manufacturer, commitments are adhered as per technical agreements, DMFs approved, updated regularly and notified.
The life science of the product quality procedures to be reviewed during the audit for documents, systems and facility. It should satisfactorily demonstrate and there should not be any conflict of interest. Auditors must perform their given task competently to ensure the company’s compliances with pharmaceutical EU / USFDA requirements along with quality standards like ICH Q7 / ICH Q10 is met constantly. Performance Monitoring & Trending Eye define how much does it see in between your audit? Does it provide necessary quality oversight?
Auditing as per requirements is designed to address the challenges of GMP auditing for the pharmaceutical industry. Auditing is a very crucial function within the pharmaceutical industries. It directly provides management with the information about how effectively the company is controlling the quality of their process and products. The API Audit for a defined active pharmaceutical ingredient to be performed on the specific site is being accepted by the regulatory authorities as proof of the GMP compliances of the API manufacturer, based on SMF submission followed by DMF submission / Dossier / ANDA/ ANDS followed by strict adherence of the GMP Compliances at the site during site audit. Such a GMP audit must be performed regularly, every two to three years. A GMP audit in the form of third party audit by contract partners is openly permitted.
GMP readiness and compliances is expected to be allied at all time during the audit. This is the reason now agencies are not giving enough time for audit preparation; it is short notice or surprise audits. The expatiations from the companies are with a constant and high level of GMP – Compliance implementations and do not need to specifically prepare for upcoming inspections with extra work or efforts.
During the audit all the team members should behave open, honest and should clearly communicate in order to maintain an inspection situation of trust and confidence. There are still certain open challenges like
- Difficulty in interpretation of GMP Guidelines: what it is really written / meant / expected to do?
- Country to country certain GMP guidelines interpretations
- Cultural understanding of GMP guidelines
It goes without saying that audit is a sampling type; it is not possible to look at all the documents within the specified time. At times if the certification audit is stricter than the international GMP audit, in certain cases the customer may not accept openly the requirements, therefore the GMP regulations and guidelines have to be well understood and followed by exporters, and even certified compliance industries should always be welcoming in the interest of the organization the requirements/ interpretation of the auditor as per desired guidelines.
The maintenance and continues improvement level of GMP within the organization must be subjected to ongoing self audits , internal audits, supplier audits, certification audits by all levels within the company. Regular inputs on CAPA, Investigation results from non-conformities and/or major/critical deviations, market complaints, Annual reviews with the management, product reviews, providing suitable measures and means for GMP, understanding of GMPs should be constantly developed by suitable training measures for the employees.
Company should make sure that audits and performance monitoring & trending provides a clear view about vendor’s operations and controls.
A pharmaceutical company is ultimately responsible to ensure processes are in place to assure the control of outsourced activities and quality of purchased materials. These processes should include quality risk management and include
- Assessing prior to outsourcing operations or selecting material suppliers, the suitability and competence of the other party to carry out the activity or provide the material using a defined supply chain (e.g., audits, material evaluations, qualification).
- Defining the responsibilities and communication processes … in a written agreement between the contract giver and contract acceptor.
- Monitoring and review of the performance of the contract acceptor or the quality of the material from the provider, and the identification and implementation of any essential improvements.
- Monitoring incoming ingredients and materials to ensure they are from approved sources using the agreed supply chain.
Vendor qualification program should provide adequate evidence that the manufacturer can consistently provide reliable and safe materials. Vendor should be monitored and regularly scrutinized to assure ongoing reliability. It is the manufacturer's responsibility to ensure that raw materials received are suitable and approved by the quality unit prior to use
It is always believed that the efforts should be constant in maintaining and improving the GMP level, which lead to successful growth with GMP compliance level only if it is supported by all employees. The relay from board members/ Managing Director to work force is responsible for quantity, safety and efficacy product throughout.
(The author is Director – Operations, Integrated Global Regulatory Services,Bengaluru)