Recently Published Interview
REGULA INSPECTION SERVICES INTERVIEW
Regula Inspection Services is a young company that aims to provide high quality, technically reliable and high value added inspection services especially for Pharmaceutical, Biotechnology, Medical Device Manufacturers and Suppliers. Deniz Edik is one of the founders of the company and has a reasonable background in Pharmaceuticals.
She is an expert who has worked in various departments for multinational and local Pharmaceutical companies and suppliers for many years. Deniz Hanım, who we believe will be one of the successful Women Entrepreneurs in our country, says that she aimed to establish her company which is composed of experts with sector experience to reach a wider audience. We talked with her about her company and services.
WINALLY: Have a nice day Mrs. Edik, Regula Inspection Services made a very fast introduction to Pharmaceuticals, Biotechnology and Medical Device sectors. Could you tell us about Regula Inspection Services?
RIS– Hello. Regula Inspection Services was established in order to provide Auditing Consultancy Services to Biotechnology, Medical Device sectors, mainly Pharmaceuticals. All of the GMP Auditors in the RIS team are IRCA-Certificated Lead Auditors who have worked as Lead Auditors and Managers in the Pharmaceutical Industry for many years.
WINALLY: What was your goal when establishing Regula Inspection Services and what kind of a return do you expect?
RIS: As we know, GMP (Good Manufacturing Practices) is a comprehensive set of systems consisting of an extremely strict set of rules which the Pharmaceutical, Biotechnology and Medical Device Industries must comply with. Turkish Medicines and Medical Device Agency (TMMDA) which was approved as a new member at the end of 2017 officially by PIC / S mentions the importance of GMP inspection clearly in the manual. These audits may be internal audits in which the firm controls its own Quality Management System and GMP Compliance as well as auditing of Active Pharmaceutical Ingredient, Excipient and Packaging Material Manufacurers and Suppliers according to Local and International rules. Readers can easily reach to TMMDA’s latest directive on GMP to get a detailed information of how to apply those rules to their operations. This very critical directive will be effective as of October 21st 2018.
Pursuant to this regulation, the Pharmaceutical Licence holder shall perform Active Pharmaceutical Ingredient (API) Manufacturer and / or Supplier Audits by assigning in house Certified and Experienced auditors or by requesting an independent body to carry out these Audits on their behalf. As a result of our research, it has been determined that most of the Pharmaceutical companies have taken this service from abroad by paying high values to foreign firms and auditors.
RIS comes into play at this point. We would like to provide these services with our experienced GMP Auditors who have IRCA Lead Auditor Certificates. The need for Certificated and Experienced Professional Auditors is increasing day by day in our sector, which is very dynamic and changes constantly. Today, the issue of trust in GMP inspectors, who has already carried out a few audit activities in the past, but did not have an International Auditor Certificate or was not recognized by an accredited International organization, is a very hot topic.
WINALLY: In this case, Auditors who do not have GMP Lead Auditor Certificate with related experience and skills will not be accepted, will they?
RIS: Although it has not yet gained an official status, it is possible to say that the first choice will be in this direction. My opinion is Absolutely YES
WINALLY: We want to ask in support of what you’re saying, so far, how did companies perform GMP Inspections before RIS?
RIS: The number of experienced and skillfull GMP Auditors who are recognized by an accredited Institutions as Certificated Lead Auditor is growing. There are many organizations that claim to certify Auditors according to ISO 9001 QMS. However they do not have any GMP concept. They are not expected to be. In particular, I would like to remind you that some Pharmaceutical companies that intend to get rid of this obligation by ISO 9001 System in the medium and long term are forced to deal with serious GMP deficits. And this is something that TMMDA and other International Regulatory Agencies are unwilling to accept.
WINALLY: Can you detail some of your GMP Audit service?
RIS: We aimed to exceed the customer requirements and expectations when establishing our company. For this purpose, we will carry out GMP Audits in accordance with the guidelines of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP), which are requested to follow by API, Excipient, Packaging Material Manufacturers / Suppliers. In addition, we will carry out Audits of Sterile and Non-Sterile Manufacturing Facilities, Contracted Laboratories, Herbal Medicinal Products Manufacturers, Biologicals Manufacturers, especially Vaccine Production, Medical Gas, Radiopharmaceutical and Veterinary Medicinal Products Manufacturing Sites. We will also provide Data Integrity audits with our expert auditors on Computerized System Validation and Data Integrity. In addition, as you know, the Medical Device regulations are constantly being updated in particular the FDA regulations. Local Exporters who want to be in multiple market want to prepare the Registration Dossier in accordance with the regulations and directives of the country they will export. Taking into account the dynamics of this sector, we plan to carry out GMP Inspections according to the demands.
WINALLY: How will your customers receive this service from you?
RIS: We are holding initial meetings with our clients and trying to understand what they want and expect. Following the acceptance of our service quote, we prepare our audit plan, carry out the audit and send them our detailed report.
WINALLY: Will your company only offer an Audit Service?
RIS: No. In addition to GMP Audits, we will have many different services. We may bring these services together under the title of Consultancy. When it comes to the Pharmaceutical sector, it is easier to examine the current situation and solutions. Our primary aim is to provide comprehensive consultancy programs to our customers. If we list the most critical problems of or clients they face we can see unresolved issues of preparation to FDA, MHRA, EMA, PIC / S, TMDMA inspections, untrained experts, time budget constraints.Our company is a solution partner with the following activities; Remediation Services, Inspection Readiness, Regulatory Mock Inspections & Gap Analysis, Audit Partnership, Due Diligence Inspections.
WINALLY: Can you briefly tell us about these services?
RIS: Sure. In addition to the most important services, Audits and Inspection Preparations, we offer the Remediation Service to our clients who have recently passed the Audit and have serious findings. We identify the Real root causes of the findings in the audit report, initiate Corrective Preventive Actions, and then prepare responses by appropriate terminology and format then finally provide documentation support. We are conducting a Regulatory Mock Inspections together with the team of our clients, who are preparing for the Inspection. The fact that this activity is similar to the actual audit is one of the most important issues. Our customers may not have a planned audit recently, but they still would like to find out at what level they are in the GMP Compliance and Quality Management System and to take the necessary actions on time. In such cases, we offer the ”Gap Analysis“ service. From time to time, acquisitions, mergers or a search of a new manufacturing and / or laboratory service can come into question. Here again, we are conducting “Due Diligence” in order to enable our clients to easily adapt to these developments and try to offer the most appropriate solution. Our clients would like to change the current suppliers and / or manufacturers that they have been working with for many years. In such cases where urgent action is required, we find the appropriate Supplier / Manufacturer and support our clients in their Supplier Qualifications. Our another useful service is “Audit Partnership”
Regula Inspection Services performs GMP Audits of API, Excipient, Packaging Materials where from the same source on behalf of its clients with a joint audit agreement and prepares a detailed report.
WINALLY: Will there be any services abroad except for companies operating in our country?
RIS: Absolutely. Initially, we want to respond to the needs of our local customers. We are aware of the demands and expectations of the Healthcare Sector and the Authority. We would like to use our existing energy to become an International recognized Audit company with the quality of the services we offer and our qualified Certificated Auditor team. We also have a few business ideas that are about to be matured for the future, and we will be sharing them with our clients soon.
WINALLY: How can companies reach you in the shortest way?
RIS: They can contact our company on our web page. They can fill in our contact form or contact us by phone. https://www.regulainspection.com/
WINALLY:What you have shared with us contains really useful information to shed light on our sector. We want to express once again that women entrepreneurs should be supported in our country. Deniz Hanım we wish you and your team superior success and we believe that your services will exceed our country’s borders in a short time.
RIS: I would also like to thank you for giving me this opportunity.
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