PharmAssess Audit Reports Operational Consultancy GMP Auditing Services Regulatory Affairs.

Transcription

1 PharmAssess Audit Reports Operational Consultancy GMP Auditing Services Regulatory Affairs

2 The Market Leader in GMP Audit Reporting PharmAssess audit reports are accepted by all Regulatory Authorities worldwide. PharmAssess is Rephine s third party GMP auditing service. Pharmaceutical manufacturers are audited and the audit report is available to customers of the manufacturer. PharmAssessreports can replace the need for customer audits. The PharmAssess service enables Manufacturing Authorisation Holders to meet their regulatory requirements (2004/27/EC) and also satisfies the most stringent QP requisites. Reduced costs for manufacturers PharmAssess audits are undertaken at no cost to the auditee companies and the availability of the reports to customers enables a significant reduction in the number of audits carried out at production sites. Disruption and management time involved in audits and remedial actions is reduced. Reduced costs for buyers The cost of a PharmAssess report is typically less than half the cost of commissioning an audit or undertaking it oneself. Truly Independent Impartial GMP auditing results in the production of a wholly independent report. Exceptional Quality Reports are comprehensive and detailed. For example, PharmAssess reports comply with ICH Q7 and Q9 for API manufacturers, PS9001 for packaging suppliers and IPEC-PQG GMP for excipient suppliers. Moreover, PharmAssess reports are customised for each MA holder and updated periodically. The report covers all the products manufactured at the audited site, together with a remedial action plan (CAPA) for any deficiencies found. Essential requirements are covered All PharmAssess reports include the vital ingredients: Name and Curriculum Vitae of the auditor The exact address of the manufacturing site audited Date of audit List of products covered by the report Detailed report of the findings 2

3 Reports are updated PharmAssess reports include an update on the remedial action plan and eventual closure of the audit. PharmAssess audits are repeated every 3 years providing continual GMP compliance statements. Enhancing Your Business Performance PharmAssess will supplement the efforts of your auditing department, satisfying QP and legislative requirements. Rephine s PharmAssess service can improve the relationship between manufacturer and supplier, by allowing time previously spent on audits to be used more productively, focusing on specific issues. PharmAssess reports are available immediately Customers are able to purchase reports from the extensive PharmAssess library, and the reports are delivered within days. PharmAssess reports are often available of suppliers where access to audit is difficult, or sometimes impossible. Rephine also conducts audits on request. Highly Qualified Experienced Auditors Rephine s trained auditors are all specialists in the Pharmaceutical industry and have extensive operational experience in either manufacturing or quality management. Many of the auditors are QPs. FAQs Do the regulatory authorities accept PharmAssess third party audits? Yes, the regulatory authorities accept independent third party audits and welcome audits from the PharmAssess library. What standards are used to perform the GMP Audit? Each audit will use EU GMP standards as a minimum. Other regulations will apply in accordance with the type of supplier being audited. How is confidentiality ensured? A confidentiality agreement is in place between Rephine, the supplier, and the purchaser. PharmAssess reports are provided in a highly secure electronic format and specifically personalised for each purchaser. As a manufacturer, do I have control over who buys our audit? Yes, Rephine will seek permission for sale on every request to purchase a report and the manufacturer has the right to veto the sale of the PharmAssess report. 3

4 Consultancy Services Provided by Rephine Rephine has an enviable record of consultancy in the Pharmaceutical Industry. Based in the UK, Rephine operates globally and has provided services in most parts of the world, and its knowledge of regulatory requirements is exceptional. Rephine provides a wide range of clinical and regulatory services for the pharmaceutical, medical device and biotechnology industries, and Rephine Consultants are all highly qualified and experienced scientists who have worked exclusively in the industry. Rephine assists in meeting challenges in performance improvement, in production efficiency, and cost effectiveness as well as in meeting regulatory requirements, strategic planning and technology transfer. The Rephine consultancy services apply to a wide range of suppliers including API manufacturers, dosage formulators and excipient manufacturers. Services cover all aspects of manufacture, from sourcing to safety and training. Details of past projects undertaken can be provided within the limits of confidentiality. The Rephine services are underpinned by the highest quality standards, attention to detail and close relationships with clients so that project objectives are met efficiently and cost effectively. The highest ethical and confidentiality standards are maintained at all times. Services provided: QP Services Permanent & Temporary QP Cover Product Release Quality System Review & Implementation Risk Management Supplier Assessment Review & Management Quality Management System Quality Manual Development & Upkeep Site Master Files Test Methods Technology Transfer Product Recall Procedures 4

5 Training Supplier Assessment Programmes EU Supplier Assessment Requirements Auditor Training Risk Management Systems and Procedures GMP & GDMP API Sourcing Advice on the selection of GMP Compliant API manufacturers worldwide Assistance in developing business with API manufacturers worldwide Suppler Evaluation Project Management GMP Project Assessment Gap Analysis Project Design & Implementation Change Management Scale up Auditing ICH Q7 API Audits Finished Product site Audits Pre-inspection Approval Assessments GMP Gap Analysis Due Diligence 5

6 GMP auditing Rephine Background Founded in 1998, Rephine is a UK based company with headquarters near Cambridge and branch offices in India, China, and Italy, allowing Rephine to continue its development of emerging markets whilst serving the existing global pharmaceutical industry. Rephine is a pharmaceutical consultancy specialising in GMP Auditing, covering APIs (to ICH Q7and Q9 standards), intermediate products, excipients and packaging audits. As a result of its experience and expertise, Rephine is a leader in third party GMP audits, having carried out hundreds of audits worldwide. GMP Auditing Rephine can help pharmaceutical manufacturers meet their regulatory requirements for GMP auditing. Rephine offers a comprehensive, fully independent, third party GMP auditing service that produces high quality audit reports more economically than manufacturers undertaking the audits themselves. Benefits of the Rephine GMP Auditing Service: Is a fully independent and confidential third party audit service. Only uses auditors who are highly experienced and qualified. Many of the auditors are QPs. Produces exclusive audit reports that are detailed and comprehensive which fully address all client specific needs. As part of the audit report, clients receive a schedule of corrective actions to be undertaken, updates as indicated by the findings of the audit and a final close out document, confirming all corrective actions have been completed. Provides high quality audit reports that have been accepted by QPs and Regulatory Authorities in 30 countries including the MHRA and EMA. The audit report makes a statement of compliance with acknowledged GMP auditing quality standards that is accepted globally. Audit reports are supplied in English in the recommended and most up to date secure format: a customer labelled CD ROM, which is fully secure and password protected. All Rephine audit reports adhere to recognised guidelines and layout. 6

7 Rephine Regulatory services Rephine can provide regulatory services to pharmaceutical companies, either as support to internal staff or as a turnkey solution. Rephine s regulatory work is worldwide and up to date with international legislation, guidelines and customer practices in all relevant countries. Regulatory activities undertaken include: Making submissions to regulatory authorities for marketing authorisations and applications for quality certification Product compliance with the regulations of the European Medicine s Agency, FDA, or national Regulatory Authorities Collecting, collating and evaluating appropriate scientific data for regulatory applications and submissions Developing and writing clear arguments and explanations for new product licences and licence renewals Preparing submissions of licence variations and renewals Writing clear, accessible product labels and patient information leaflets Planning and developing product trials and interpreting trial data Advising scientists and manufacturers on regulatory requirements Providing strategic advice to senior management throughout the development of a new product Undertaking and managing regulatory inspections Reviewing company practices and providing advice on changes to systems Liaising with, and making presentations to, regulatory authorities Negotiating with regulatory authorities for marketing authorisation Specifying storage, labelling and packaging requirements The Rephine regulatory division is based in UK but undertakes activities in most parts of the world. Please contact Rephine s UK head office for further information. 7

8 Head Office: Lower Gatley, Steeple Morden, Herts. SG8 0NR UK Tel: Regional Offices China: Shanghai India: Mumbai Italy: Bologna Latvia: Riga