GMP system implementation

GxP services:

• Quality system design, handling, upgrade – GAP analysis,
• Support in Agencies’ inspections,
• Audits at the manufacturer production sites, 3rd party or subcontractors,
• Support in qualification and validation of facilities/operations/systems and equipment,

Engineering and architectural consulting services.

Good Manufacturing Practice (GMP) guidelines are known to be written relatively broadly and yet covering and often highlighting specific cases, such as manufacturing of sterile active substance (API), chemical, biological or advanced therapy medicinal products (ATMP).

When thinking about a specific process, many often wonder and may ask themselves:

• Which standards are relevant?
• What requirements are mandatory and what is just optional advice?
• What strategy should be used?
• What is mandatory documentation?

SciencePharma, as a professional GMP consultancy, provides comprehensive services related to the implementation of the GMP system to pharmaceutical companies helping them to obtain manufacturing or importation license and a GMP certificate.
In addition to those activities, we provide highly competent QP services including drug product certification. As part of the process, we discuss, analyze, and propose custom-tailored solutions, develop policies and procedures; and conduct training and internal audits.
The unique combination of consulting and engineering services allows us to develop and implement seamless GMP solutions and services that are always up to date and operational. This in-depth GMP knowledge and experience makes SciencePharma consultants unique in the market.

There may be a plethora of these type of questions, which you may find yourself asking.

Specific GMP requirements need to be applied depending on the type of substance and process. The scope of requirements placed on manufacturers of API differs from those placed on manufacturers of a sterile drug product. Biotech/ATMP production has its own unique set of requirements as well.

In such cases, a competent consultation about detailed GMP aspects may be necessary. As a highly experienced company, SciencePharma provides such customer-tailored services which combine full attention to details and at the same time not losing a broad pharmaceutical perspective.

If you wish to expand to the European Union (EU) market, but have no EU GMP certificate or the scope of your current certificate is not sufficient for your needs, the GMP upgrade service provided by SciencePharma is something for you. We can assist in reaching your goals whether you have been in the “GMP market” for many years or have just started your GMP journey.

Perhaps you are unsure how to proceed with GMP in your new facility, analytical laboratory or warehouse. If this is the case, do not hesitate to consult us. We will surely guide you through this process step by step. Passing official inspections and audits of clients have become an increasing challenge. A GMP-compliant quality system should be solid and coherent and in particular must not contain any major deficiencies or gaps. If you are unsure of the proper GMP implementation or don’t know whether your GMP system meets current rapidly changing GMP requirements, the GAP analysis will be the tool to use. Our experts will assess your GMP and prepare a detailed GAP report with concrete suggestions whenever applicable. You will then be able to adjust and prepare for inspections.

Being in the GMP field we cannot resist the impression, that GMP requirements are expanding with time thus becoming more complex. With the new guidelines and defined requirements, the authorities increase their attention to detail, hence it is expected that manufacturers should meet higher and higher standards. Following the ever-changing requirements, SciencePharma has assisted pharmaceutical businesses for two decades in developing and efficiently implementing EU-compliant effective quality management systems together with the Quality Risk Management Systems (QRMS). In recent years, our experience contributed to the fact, that many companies (including third-country companies) implemented GMP requirements from scratch, successfully passed the GMP certification and eventually received respective EU GMP certificate. We partnered with many types of companies:

• importers of medicinal products,
• quality control laboratories,
• manufacturers of ATMP products,
• manufacturers of biological medicinal products, sterile or inhalation products
• many more.

A key to a good GMP system is to comprehensively think through the requirements and then implement appropriate solutions accordingly. A deep focus should be put on key aspects, such as deviation, Corrective And Preventive Action (CAPA), complaints, change control, and many other general procedures that are always checked during an inspection. These are the foundations that need to be defined prior to building other system documents that are necessary for the proper conduct of GMP processes. Experts at SciencePharma possess the know-how (e.g. typical inspectors’s expectations) to prepare such documents. They can provide you with a number of ways for resolving currently discussed GMP issues or maintenance and upgrade of quality system(s) in the future.

An update of the GMP system can also take place when the company is dealing with new processes, new products or new markets. The goal of a GMP upgrade is to make the system state-of-the-art and manufacture the products with confidence that their quality requirements are met, thus they are safe for patients. SciencePharma’s experts could help you to find areas for improvement. In order to achieve it we can examine the condition of the production area, utility systems and equipment, review and examine the procedures and records and interview key personnel in the manufacturing area.

Has an official inspection been scheduled? This is where SciencePharma steps in as a partner. We will do everything we can to make the inspection successful. We have many years of experience in supporting companies before and during inspections. When the clock is ticking and the routine audit is approaching, you may find yourself in a position of no time to conduct an audit of your supplier or contractor. This is a service, which we also offer, since performing audits as a subcontractor is our daily routine. If you plan to cut audit costs, there is always a chance to solicit a full or partial remote audit.

SciencePharma is a leading GMP consultancy company that specializes in assisting the next-generation pharmaceutical production sector such as advanced therapy medicinal products and medical devices. We assist our customers in terms of qualification and validation, engineering and architectural consulting services. Each process is tailored to the organization, taking into account current requirements, predicting Inspectors expectations while keeping low-cost in mind.

We offer expertise and consultation services to assist your company with compliance with GMP requirements. Our experts are highly certified and trained in the relevant legislation, standards, and guidelines, including but not limited to: GMP/GDP guidelines, ISPE guidelines, such as GAMP-5, FDA, TGA, and PIC/s.

Benefits of cooporation:

• Solutions to meet individual requirements precisely tailored to the product, process, and project.
• Needs-oriented consultants with well-established and many years of practical experience, knowledge of regulations and many successful ending projects.
• Flexibility in terms of time and scope.
• Partnership-based advice with regard to profitability.
• Developing a master plan to determine the next steps which might be used for the economic evaluation of the GMP upgrade.
• On-site or online consultancy and project execution.
• Support during official inspections, as well as pre-inspection training
• Evaluation of manufacturing process consistency based on the application dossier.

Online/onsite audits of contractors (API, excipients and drug product facilities) from herbal through sterile manufacturing up to ATMP production, places of storing materials—warehouses; analytical laboratories; and supply chain audits to be in line with GxP requirements. For your time saving we also provide CAPA management upon request