The services provided by PharmAK cover the scope necessary to achieve the client’s objective:

• obtaining a Manufacturing and Importation Authorisation (MIA) for the manufacture/import of medicinal products, including investigational medicinal products (IMP),
• obtaining a Wholesale Distribution Authorisation,
• obtaining a permit for the manufacture of controlled substances, including the processing / manufacture of hemp and cannabis.
• obtaining a Wholesale Distribution Authorisation for controlled substances
• obtain a Registration of Active Substance Manufacturers, Importers and Distributors
• preparing for inspections by competent authorities and obtaining a GMP, GDP or GDP for API Certificates,
• preparation for counterparty audits,
• preparation of (QMS) documentation.

Extensive auditing and expert experience (dozens of audits conducted by PharmAK team at home and abroad, including third countries) will provide the Client with a reliable assessment of compliance with the requirements both within its own organization and will allow to assess the qualifications of a potential contractor.

As part of our audit services, we offer, in addition to the assessment and preparation of a detailed audit report, the preparation of a schedule of corrective and preventive actions (CAPA) and gap analysis (Gap Analysis).
Quality audits are carried out onsite or remotely (remote audit), depending on the client’s needs.

GxP quality audits include, but are not limited to:

• manufacturing of medicinal products (solid forms, injectable forms, radiopharmaceuticals, herbal products, controlled substances),
• manufacturing of active pharmaceutical ingredients (APIs) and excipients, including sterile active ingredients,
• manufacturing of API and/or pharmaceutical raw material of plant origin (medical marijuana)
• import and distribution of active pharmaceutical substances (API) and excipients, including controlled substances,
• manufacturing of cosmetics, dietary supplements and medical devices,
• import of medicinal products / investigational medicinal products, active pharmaceutical substances and excipients,
• distribution (pharmaceutical wholesalers, brokers, logistics and transportation companies),
• analytical and microbiological laboratories,
• assessment of compliance with the GACP standard for the manufacture of starting materials for the production of plant-derived APIs,
• subcontractors (outsourcing), suppliers, customers and service providers,
• subcontractors providing manufacturing/ logistics services for clinical trials – on behalf of Clinical Research Sponsors and Clinical Research Organization (CRO) companies.

The scope of consulting includes:

• preparing the organization for obtaining a Authorisation / license / inspection of competent authorities / GMP or GDP certification / contractor audit / registration,
• implementation of the Pharmaceutical Quality System at the manufacturing plant / at the importer of medicinal products and investigational medicinal products / at the pharmaceutical wholesaler / at the API manufacturer, importer and distributor
• compliance assessment of ongoing activities, among others – Product Quality Review (PQR) – Periodic QMS reviews (Management Reviews) – Qualification of suppliers of starting materials and services – Qualification / validation of systems and processes – Qualification of suppliers and customers of wholesalers – Quality Risk Management (QRM) – Change Management (CC) – Supervision of Corrective and Preventive Actions (CAPA), and others
• Analysis and optimization of authorized / registered processes – Gap Analysis

The area of our activities is to look for and analyse:

• inconsistencies of the applicable QMS with respect to GxP recommendations and requirements,
• root causes of occurring problems (Root Cause Analysis).
• Quality risks and their management (Quality Risk Management),
• the possibility of effective and timely implementation of the Schedule of Corrective and Preventive Actions after inspection by competent authorities
• needs for change in processes and, if the need is confirmed, to make these changes effectively, based on the Risk Analysis, Gap Analysis or Feasibility Study conducted
• key areas or elements of areas requiring process improvement or optimization if such opportunities have been identified.

We provide industrial hemp producers and processors with support in achieving the highest quality standards of the products they offer (dried hemp flowers or CBD oils) and compliance with applicable laws and guidelines, including but not limited to.

• Substantive and process support in the preparation and obtaining of a Permit for Manufacturing, Processing, Importation or Distribution of Narcotic Drugs or Psychotropic Substances issued by the Chief Main Inspectorate (GIF), which is an essential document for companies processing industrial hemp for the food or cosmetic industry.
• Consultation/ support in the development of a system of organizational and procedural safeguards for the manufacture, quality control and storage of controlled substances.
• Preparation of necessary system and process documentation, including procedures and instructions
• Provision of necessary training and support to the Responsible Person for Supervision of Controlled Substances
• Assessing the feasibility of compliance with the GACP standard for the manufacture of starting materials for the production of plant-based APIs

We provide support in meeting the requirements of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) at all stages of the manufacturing and distribution process – starting with the production of starting material for API production in the GACP standard through the production of API – active pharmaceutical substance (GMP, GDP for API), then the production of medicinal product (pharmaceutical raw material) – (GMP) to the wholesale distribution process (GDP).

The services and consultations offered include.

• Assessment of compliance with the GACP standard for manufacturers of starting materials for the production of active pharmaceutical substances of plant origin (audit of suppliers of starting materials for API production)
• Development of a concept for the construction/ reconstruction of an active substance manufacturing plant taking into account the GMP guidelines for API manufacturers.
• Development of a system of physical organizational and procedural safeguards for manufacturing, quality control and storage of controlled substances.
• Substantive and process support in the preparation and obtaining of Registration in the Register of Manufacturers, Importers and Distributors of Active Substances maintained by the Chief Pharmaceutical Inspectorate (GIF)
• Preparation for obtaining GMP/ GDP Certificate for APIs
• Substantive and process support in the preparation and obtaining, issued by the Chief Pharmaceutical Inspector – Manufacturing and Importation Authorisation (MIA) and GMP Certificate for the Manufacturer
• Substantive and process support in preparing and obtaining, issued by the Chief Pharmaceutical Inspector – Permit for Manufacturing, Processing, Import or Distribution of Narcotic Drugs or Psychotropic Substances for Pharmaceutical Raw Material.
• Substantive and process support in the preparation and obtaining, issued by the Chief Pharmaceutical Inspector – Wholesale Distribution Authorisation in controlled and GDP Certificate.
• Preparation of registration documentation in CTD format for pharmaceutical raw material.
• Substantive and process support in the preparation and obtaining of Marketing Authorization for pharmaceutical raw material issued by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.