GMP

 

GENERAL INFORMATION

The GMP (Good Manufacturing Practice) standard is a system of rules, regulations and guidelines for production:

  • medicines
  • medical devices
  • products for diagnostic purposes
  • food products
  • food additives
  • active ingredients

Unlike the quality control procedure by examining samples of such products which ensures the suitability for use only of very these samples (and, possibly, batches produced in the near future), the GMP standard reflects a holistic approach and regulates, assesses the actual production parameters and laboratory testing.

In order to standardize the quality of medical services the GMP standard is applied together with the following standards:

GLP (Good laboratory practice)
GCP (Good Clinical Practice)
GDP (Good distribution practice)
GACP (Good Practice for Cultivation and Collection of Medicinal Plants)

Since May 6, 2017 in the Eurasian Economic Union, the uniform rules of Good Manufacturing Practice (GMP) for the production of medicines entered into force.

 


BENEFITS OF IMPLEMENTATION (CERTIFICATION)

  • the possibility of exporting medicinal products to the EU countries;
  • Increasing consumer confidence, forming a recognizable and authoritative brand, increasing the commercial value of products;
  • automatic compliance with national and international regulatory requirements;
  • ensuring the economic sustainability of the company in the manufacturers of medicines market and the opportunity to enter new markets;
  • improving the quality and product safety level;
  • ensuring successful competition in tendering, supplier selection procedures;
  • clear alignment of the company's business processes, efficient allocation of internal resources, responsibility and authority of personnel within the management system.
     

WHY BELPROJECTCONSULTING?

Working with our company, you can get:

  • Confirmation the pharmaceutical quality management system conformity in the National System on the part of the leading certification body in the CIS;
  • Possibility to reduce the cost of the service by attracting qualified Russian-speaking consultants and auditors;
  • To replenish the knowledge base and ensure the competence of the staff in the wide selection of our training seminars with leading expert practitioners and auditors in their professional fields.


GENERAL SCHEME OF WORK ON INTRODUCTION AND CERTIFICATION OF PHARMACEUTICAL QUALITY SYSTEM FOR GMP REQUIREMENTS

General detailed plan for the development of a pharmaceutical quality system, assistance with its implementation, preparation and passing of a FSC certification audit in accordance with GMP requirements

1. Development of documentation on the pharmaceutical quality system:

  • Quality guide;
  • Job descriptions (JD) of key personnel within the framework of FGC (Regulations on the Authorized Person, CI of the Production Manager, Head of the JCC, Chief Engineer);
  • Documentation system and types of documents;
  • The procedure for storing, distributing and replacing documents;
  • The encoding documents procedure;
  • Purpose and content of the standard operating procedure and the technological instruction;
  • Development and approving specifications procedure;
  • The finished medicinal products series dossier compiling, filling and storing procedure;
  • Fill in the forms, the order of filling;
  • The order of transfer of the series of finished medicinal products dossier in the archive. Archival storage rules;
  • Organization and conduct of internal inspections at the enterprise;
  • The order of work with products that do not meet the requirements of regulatory documents;
  • Review of claims and withdrawal of products from the market;
  • The procedure for issuing permits for the sale of finished products;
  • The finished medicinal product serial number assigning procedure;
  • The actions of the company personnel in detecting a production error;
  • Identification of the status of raw materials, packaging materials and finished products;
  • Verification of measuring instruments;
  • Maintenance and repair of equipment;
  • Evaluation and approval of suppliers (producers) of raw materials and auxiliary materials. The approved suppliers list approving procedure;
  • Measures taken at the company to combat insects and rodents;
  • Basic principles of validation measures organization at the company;
  • Personnel training system for the company;
  • Health and personal hygiene practices;
  • The personnel medical examination procedure;
  • Corrective and preventive actions;
  • Quarantine storage of raw materials, auxiliary and packaging materials, bulk, intermediate and finished products;
  • The under the contract work order organization (outsourcing activity);
  • Risks management;
  • Data analysis and a quality review preparation;
  • Working with changes and deviations;
  • Working with complaints;
  • The raw materials in the storage area acceptance and registration procedure. The acceptance report;
  • The finished products acceptance and registration procedure;
  • Control of climatic parameters of air in warehouses;
  • Procedure for the deviations of climatic parameters of air in the warehouse from the permissible values;
  • Cleaning in storage areas and sanitary facilities;
  • Technological instruction for medical products production;
  • Technological instruction for cleaning the premises;
  • The issuing finished products procedure and issuing permission for the implementation by the Authorized Person
  • Procedure for sampling raw materials (oxygen liquid medical substance), input control and issuing/rejecting permission for use;
  • Draft route map (dossier on a series) development for the oxygen production
  • Insects and pests control measures.

2. Initial control and information activities for preparation for GMP certification:

 

  • Conducting a production survey (with departure);
  • Technical training of specialists;
  • Methodological assistance in the pharmaceutical quality system documentation requirements implementation.

3. Development of GMP certification additional documentation:

  • Validation master plan;
  • The production site dossier;
  • Appraisal plan for warehouses;
  • Validation plan and/or report on the oxygen production process validation;
  • Audit plan preparation, self-inspections;
  • Oxygen production risks analysis;
  • Training program;
  • Hygiene and Sanitation Program;
  • GMP certification corrective actions list development (based on audit results);
  • Pre-certification audit;
  • Methodological assistance in eliminating inconsistencies in the documentation, if they are identified in a certification audit.


ORGANIZATION OF THE PRODUCTION CAPACITY FOR THE OPTIMAL IMPLEMENTATION OF GMP (FOR BUILDING INDUSTRIAL PLANTS)

Our company provides services both in the development of the GMP management system and helps in building the production flow and production infrastructure in accordance with the requirements of Good Manufacturing Practice at the sites under construction prior to production start-up.
An indicative list of the main works carried out by our consultants under the agreement on the organization of production flow:

  • Project documentation analysis, nomenclature of planned for production and technological schemes, primary audit of the building under construction for the set of recommendations preparation and an example of the arrangement of production and auxiliary sites, technological equipment, schemes for the movement of raw materials, personnel, products;
  • Preparation of air and water treatment systems recommendations and requirements , organization of clean rooms;
  • Technological equipment purchase customer consultation;
  • Preparation of the required validation documentation list;
  • Preparation of the necessary production documentation list and requirements for it
  • Preparation of a production site quality system documentation list;
  • Preparation of a Report on the Organization's implementation of the activities developed at the first stage, assessing the Organization's readiness for further implementation of the GMP system.

 

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