What is Pharma Consultancy?
Pharma Consultancy provides assistance of product development in biotechnology, pharmaceutical and device fields. It is an affair of specialists that aims to advice and train nonclinical testing, clinical trial design, manufacturing, regulatory agency interactions, submission preparation and so on.
The Importance and Advantages of Pharma Consultancy
The Pharma Consultancy is important to ensure oncology growth by meeting the goals and making the most of the investment. It can help on market strategy where client will adopt the market trends to roll the company globally. It also helps on how to trim costs by focusing on investments and how to grow strategies.
Standards of Pharma Consultancy
The following services can be offered to Pharma and Cosmetic industry
Pharmaceutical Industry (API & Formulations)
Facilitate interaction with regulatory agencies, such as in meetings and conference calls, negotiations during development stages, submissions and submission approval process:
Help you respond to regulatory agency questions.
GMP Auditing
Cosmetic & Excipient Industry
Neozenith Consulting Services: Consultancy and Assistance as per 21 CFR Part 210, Part 211
Neozenith consultants can help you with the complete Pharma Consultancy process from documentation, implementation, trainings, internal audits and USFDA Approvals.
The process basically encompasses
Drug Master File (FDA DMF)
Drug Master File (FDA DMF) is a confidential document submitted voluntarily to the FDA by human drug manufacturers, processors, packagers, and stores. DMF contains information about production facilities, processes, packaging, quality control, and storage products. FDA DMF is generally submitted by manufacturers of Active Pharmaceutical Ingredient (API), Drug Substance, Drug Intermediate Substance, and Drug Packaging Material.
Drug master file usually contains the components/ingredients, chemistry, process technology, quality controls either of drug substance, excipient, or packaging material. Drug Master File has a significant role in finished product drug applicants’ NDAs, ANDAs, and INDs. So, careful preparation of files by an expert is highly essential for successful submission.
Drug Master File Types
Drug Master File TYPE I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable).
Drug Master File TYPE II: Drug products or substances or intermediate and or materials used for drug preparation.
Drug Master File TYPE III: Packaging Material.
Drug Master File TYPE IV: Excipient or Colorant or Flavour/Essence or material used in the Preparation.
Drug Master File TYPE V: FDA Accepted Reference Information.
Regional DMFs:
The DMFs generated for regions (excluding USA and Europe) are covered under Regional DMFs for the following countries: Canada, China, Turkey, Brazil, Korea, South Africa, Australia, Syria, and Saudi Arabia. Regional guidelines of the respective countries must be followed for generation and submission of the Regional Drug Master Files.
FDA Registration
FDA registration is the basic requirement for domestic and foreign establishments that manufacture or market food, drug, API, medical devices, or cosmetic products in the USA. Companies that manufacture, process, pack, or store these products in the United States may be required to register with the FDA. Here are some examples of the types of companies that require FDA registration:
It’s important to note that the FDA has specific registration requirements for each type of product, and the registration requirements for all kinds of companies are not the same.
US FDA Agent
All foreign Establishments must identify a US FDA Agent while in the registration process. This is a mandatory requirement, and without US FDA Agent, the registration cannot be completed. Neozenith Consulting Services provides US FDA Agent service to foreign food, drug, API, and medical device establishments.
FDA Registration Renewal
All Drug, API, and Medical Device establishments registered with FDA must renew their registration annually between October 1st and December 31st. Food facilities must renew their FDA registration between October 1st and December 31st of every even-numbered year (once every 2 years). The FDA may consider the products of companies that do not comply with FDA renewal requirements as misbranded and may lead to FDA detention of your products.
FDA Certification
FDA Registration or FDA registration number does not denote FDA certification or FDA approval of your facility or products. Any representation of the FDA registration number on the product label or labeling which implies FDA certification or FDA approval of a facility or product is misleading and may cause misbranding of the product.
FDA Certificate
FDA will not issue a registration certificate after completing the registration; also, FDA will not recognize a third-party registration certificate. Most Importers and Shipping companies always ask for an FDA registration certificate or proof of FDA registration from the manufacturer.
FDA Registration Fees
Neozenith Consulting Services offers the most competitive fees for FDA registration, US FDA agent service, NDC number request, Drug listing, Label review, and other services.
About Us
Neozenith Consulting Services is a globally recognized FDA, CE Marking, and ISO consulting firm headquartered in Madhya Pradesh, India with Associates and offices around the globe. At NCS, we provide a full range of consulting services to domestic establishments in FDA regulations.
If you are looking for assistance in FDA regulations, FDA registration, or US FDA Agent requirements, NCS will be the best choice. Our dedicated and experienced consultants can provide exceptional guidance on US FDA regulations. We always give you an accurate estimate of the total cost involved in each project; we will never put you in uncertainty with hourly consulting fees. NCS provides quality service at a reasonable price within a minimum time frame.
Our mission is to provide maximum benefits to our clients through the proper guidance in FDA regulations and provide the latest information about the changes in FDA regulations
EFfCI Certification
EFfCI was formed out of interest of over 100 cosmetic ingredients companies in Europe. The EFfCI published the Good Manufacturing Practice (GMP) Guide for Cosmetic Ingredients – Revision 2017, including the Certification Standard and Scheme for GMP for Cosmetic Ingredients. It is mandatory for companies in third world countries supplying ingredients to cosmetic manufacturing companies etc. to comply with the requirements and apply for certification.
The format of the EFfCI GMP Guidelines is based on the structure of ISO 9001 and the IPEC (International Pharmaceutical Excipients Council) GMP guide.
EFfCI GMP certification ensures compliance with good manufacturing practice in the production of cosmetic ingredients. It therefore guarantees that companies manufacturing cosmetic ingredients comply with regulations that ensure product quality in terms of both materials and production processes. It also enables cosmetics manufacturers to demonstrate compliance with ISO 22716: 2007 (Cosmetics – Good Manufacturing Practices guidelines) and EU Regulation (EC) No 1223/2009 on cosmetic products.
Good manufacturing practices for cosmetic ingredients. Reference EFfCI
The EFfCI certification scheme is aimed at companies that manufacture ingredients for use in cosmetic products, in order to ensure good practices in the preparation and manufacturing processes, before their distribution to consumers.
Through this certification scheme, the safety of cosmetics is reinforced through a quality management system, while minimizing the costs of quality assessment within the supply chain.
The group of cosmetic products also includes hygiene and health products, as well as personal care products (sunscreen, shampoo, soap, etc.).
Good Manufacturing Practice (GMP) is the practical development of the quality assurance concept and is based on sound scientific judgment and risk assessments.
Benefits obtained:
Neozenith EFfCI GMP Certification: Consultancy and Assistance:
Neozenith consultancy can help you with the complete EFfCI GMP Certification process from documentation, implementation, trainings, internal audits and right certification body.
EXCiPACT Certification
Regulators require excipient users to qualify their suppliers based on GMP/GDP audits and they have indicated that third party auditing of suppliers is acceptable if a creditable certification body issues certificates and audit reports by employing qualified auditors who are demonstrably credible in suitable GMP/GDP standards and in the needs of the pharmaceutical industry. EXCiPACT assembly is a non-profit organisation that owns and manages oversight of such an independent, high quality, third party Certification Scheme available to pharmaceutical excipient manufacturers and distributors worldwide.
CERTIFICATION SCHEME
The Certification Scheme can only be undertaken by a Registered EXCiPACT Certification Body employing a Registered EXCiPACT Auditor. The certification process is summarised in the following eight steps:
Step 1
Supplier selects a Certification Body from the approved list and provides them with information to issue a cost quotation, audit timetable and duration for a 3-year certification audit. This reflects the supplier’s audit scope and the organisational and operational complexity of the specified site.
Step 2
Supplier and Certification Body sign an Agreement for a 3-year certification audit of a specified site that covers its scope, audit standard(s), audit duration, audit schedule, surveillance audits and an auditor from the approved list.
Step 3
Stage 1 Audit: Auditor reviews supplier’s on-site documentation against the audit standard(s) and writes to the supplier to identify nonconformities and agrees the time needed for them to be resolved before the Stage 2 detailed on-site audit commences.
Step 4
Stage 2 Audit: Auditor undertakes a full on-site site inspection against the audit standard(s) and submits a report to include any major nonconformities to the Certification Body’s Independent Certification Board (ICB) for review and a certification decision.
Step 5
ICB makes the certification decision and issues the certificate and audit report to the supplier. EXCiPACT issues an invoice to the supplier for the Certification Fee and on receipt adds the supplier’s details to the approved list of suppliers on their website and may issue a press release.
Step 6
The certificate is valid for 3 years and surveillance audits are held at least annually to address all Scheme requirements including inter alia internal audits, actions on previous nonconformities, complaints, and QMS effectiveness. Written reports are sent to the supplier after each audit.
Step 7
A recertification audit takes place at the supplier’s request before the date of expiration of the latest certificate to confirm the continued conformity to the current EXCiPACT standard(s).
Step 8
If the supplier makes any changes to the scope of their certificate, or to the management and ownership, or becomes aware of legal proceedings with respect to product safety or legality, or of a product recall, they must immediately inform the Certification Body who will take appropriate action.
Why EXCiPACT Certification?
Who should get EXCiPACT Certification?
Pharmaceutical Excipient Manufacturers and Distributors.
How Neozenith Help you to get EXCiPACT Certification:
Good Manufacturing Practices
Good Manufacturing Practices (GMP, also referred to as ‘cGMP’ or ‘current Good Manufacturing Practice’) is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.
GMP defines quality measures for both production and quality control and defines general measures to ensure that processes necessary for production and testing are clearly defined, validated, reviewed, and documented, and that the personnel, premises and materials are suitable for the production of pharmaceuticals and biologicals including vaccines. GMP also has legal components, covering responsibilities for distribution, contract manufacturing and testing, and responses to product defects and complaints. Specific GMP requirements relevant to classes of products such as sterile pharmaceuticals or biological medicinal products are provided in a series of annexes to the general GMP requirements.
GMP Guidance
The first WHO draft text on GMP was adopted in 1968. In 1969, when the World Health Assembly recommended the first version of the WHO Certification Scheme on the quality of pharmaceutical products moving in the global market, it accepted the WHO GMP as an integral part of the Scheme. A supplementary annex on biological medicinal products was adopted by the Expert Committee on Biological Standardization (ECBS) in 1991 and establishes the general approach to the quality control of biological medicines that include products such as vaccines, blood and blood products, antigens, cell and tissue therapies, biopharmaceutical products, and others.
More than 100 countries have incorporated the WHO GMP provisions into their national medicines laws, and many more countries have adopted its provisions and approach in defining their own national GMP requirements. The WHO GMP continues to be used as a basis for the WHO Certification Scheme and prequalification of vaccines for procurement by UN agencies
Overview of GMP Certification
GMP stands for Good Manufacturing Practice, & the term is used globally for managing the control and management of manufacturing, testing and overall quality of pharmaceutical products. It defines certain guidelines that talks about the quality assurance approach. GMP certification ensures that products are produced following the quality standard norms.
Joint Commissioner is authorized by Commissioner, Food & Drug Administration, to sign & issue the certificates under the WHO-GMP certification scheme. GMP certification deals with issues like documentation, record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, sanitation, complaint handling, and process validation.
GMP requirements are not peculiar in any sense instead they are open ended and easy to implement also these requirements give liberty to the manufacturer to decide individually how to efficiently implement the necessary controls.
What is the Purpose of Goods Manufacturing Practice?
The main purpose of Goods Manufacturing Practice is to reduce the amount of risk involved in the production of pharmaceutical items. Pharmaceutical items include risks such as: (a) unexpected uncleanness in the product can badly affect the health which can further lead to death; (b) incorrect labels on containers which simply implies that patient is consuming the wrong medicine, (c) too much active or too less ingredient, (d) causing ineffective treatment or adverse effects, etc.
GMP has many authority under it such as covering all aspects of production, from the starting material, details regarding areas and equipment to the training and personal hygiene of staff. It provides the complete details regarding the procedures that yield the finished product and could affect the quality of it.
What does GMP Guidelines Directs the Certification Holders?
WHO (World Health Organization) has formed certain guidelines for good manufacturing practices. Numerous nations have defined their own necessities for GMP based on WHO GMP. Others have fit their prerequisites, for instance in the Association of South-East Asian Nations (ASEAN), in the European Union and through the Pharmaceutical Inspection Convention.
GMP guidelines require a quality way to deal with manufacturing, empowering organizations to limit or eliminate instances of contamination, misunderstandings, and mistakes. This shields the consumer from buying an item which isn’t compelling or even risky.
Most GMP prerequisites are extremely extensive and open-ended, permitting every maker to choose independently how to best actualize the essential controls. This gives a lot of adaptability, yet additionally necessitates that the producer decipher the prerequisites in a way which makes sense for every individual business.
What are the Benefits of GMP Certification?
Every pharmaceutical and medical device manufacturers follow GMP rules and procedures while some have created their own guidelines that correspond with their legislation.
Benefits for the Manufacturer
One of the primary benefits is significantly improved quality systems and quality compliance at the manufacturer. We have seen these improvements in the months leading up to GMP certification and continuing during the years immediately following GMP certification.
Benefits for the Customer
Customers will typically modify their oversight of manufacturers that have been GMP certified. Customers are aware that in order to be certified, the manufacturer must have systems in place and provide evidence that non-conformance and changes that require customer notification are handled appropriately. This assurance is typically not obtained through a one-day supplier audit that pharma companies carry out; rather, it is obtained as a result of thorough, multiple day audits of manufacturer as part of a certification audit program.
Good Distribution Purpose
Neozenith Consulting Services is one of the largest and leading GDP consultants in India. We provide quick, result oriented and easy to implement consultation and training for GDP certificate. Whether you are a small organization or a multinational corporate, our proven consultation solutions will ensure that you implement GDP standard in the most effective manner with timely project completion.
GDP medicinal products distribution system implementation with the consultants and experts of Neozenith Consulting Services not only assures 100% successful GDP certification but also improves process performance and business operations.
Consultants of our organization assist your company in your medicinal distribution management context through GDP certification to get your company GDP certified quickly with ease of implementation and in the most cost effective manner.
We make sure that GDP standard implementation does not just become a documentation activity but also a way of life for the organization that lays a foundation for Total distribution Management and medicinal distribution conscious organizational culture.
We offer onsite and online consultation solutions for GDP certification. Our customers have been utilizing our services not only for initial certification consultation but also for post certification consultation to ensure that we regularly add value to their business processes of our customers and quality standardization initiatives.
Our GDP certificate consultation services include awareness training, medicinal product distribution management policy – objectives workshop, gap analysis, documentation design including manuals, procedures, work instructions, formats etc., implementation assistance & training, internal auditor training, lead auditor training, assistance in conducting internal audit, pre-assessment audit and everything required to ensure a 100% successful GDP certification audit within scheduled project completion time period.
Biggest benefit an organization gets out of GDP is improvement in business process control through process standardization. No matter what benefits you are looking for from GDP certification, we will make sure that your organization benefits from GDP implementation and certification.
What is GDP?
GDP is Good Distribution Purpose which is related to managing the distribution of medicinal products for human use. This standard helps us to maintain product safety and quality during distribution of pharmaceutical products.
Who can apply?
Organizations which are purchasing, receiving, storing and exporting drugs/medicines for human use can apply for this certification.
Benefits of implementing GDP:
Guidelines for distribution of medicinal products include:
What do we offer for GDP Certification for your organization?
We offer GDP training, implementation, consultation, gap analysis, documentation, internal audits, pre-assessment audits, certification audit through best of the certification bodies and post certification enhancement / maintenance services to enable your organization to get the best out of GDP management system. Our services are globally accepted, authoritative and benchmarked in the field of GDP.
