Implementing GxP and ISO standards

Comprehensive practical and methodological services for pharmaceutical companies, medicine warehouses, medical device manufacturers and pharmacies: implementing GMP, GDP, GSP, GPP, ISO 13485 and ISO 9001, improving the quality management system, and preparing for certification and successful inspections.

GxP and ISO quality management standards in pharmaceuticals

GxP (Good x Practice) is a set of good practice standards and rules in the pharmaceutical sector that ensure quality, safety and compliance with established requirements throughout the life cycle of medicines, including research, development, manufacturing, storage, transportation and distribution.

ISO (International Organization for Standardization) is the organization that develops international standards for many sectors, including pharmaceuticals and medical devices. These standards help build quality management systems, manage processes effectively and ensure the quality of products and services.

Implementing good practice (GxP) requirements

GxP standards were developed to protect consumers' interests and develop international trade.

  • Initial audit and compliance assessment

  • Recommendations on identified non-conformities

  • Staff training and professional development

  • Developing standard operating procedures (SOPs) and quality documentation

  • Preparation for certification and inspections

Registration stages

Under the rules in force in the Republic of Uzbekistan, the registration of medicines includes the following stages:

  1. Step 01

    Document submission

    Uploading the registration documents to the electronic system and submitting samples to the Centre

  2. Step 02

    Expert review

    Primary (preliminary) expert review of the registration documents and samples

  3. Step 03

    Laboratory testing

    Laboratory testing of medicine samples where required under the registration procedure

  4. Step 04

    Specialised expert review

    Specialised expert review of the registration documents

  5. Step 05

    Clinical evaluation

    Clinical evaluation or clinical trials (for original and generic products, except where clinical studies are not required)

  6. Step 06

    Final decision

    Deciding on state registration or refusal based on the expert review results

Certification requirements and documents

To prepare for a GxP certification audit, the following mandatory documents must be submitted.

  1. 01Official state registration document confirming the applicant's status as a legal entity.
  2. 02Conclusions on the compliance of manufacturing, warehouse or pharmacy premises with sanitary and technical safety requirements.
  3. 03Quality management system (ISO 9001) manual and list of standard operating procedures (SOPs).
  4. 04Certificates confirming the higher education and qualifications of the responsible pharmacists.
  5. 05International validation reports for process equipment, air handling and purified water systems.
  6. 06Proof of payment of the state fee and of the inspection and audit fee.

Individual services

  • Implementing GPP in pharmacies

    We help develop SOPs, train staff and implement a quality system.

    Send a requestLearn more

  • Implementing GDP

    We help implement a quality system, develop documentation and prepare for inspections.

    Send a requestLearn more

  • Implementing GMP

    Building a quality system, documentation, staff training and preparing for certification.

    Send a requestLearn more

Frequently asked questions

Answers to questions about certificate validity, inspection control and how non-conformities are eliminated.

GMP, GDP and GPP certificates are valid for 3 years. While a certificate is valid, inspection control is carried out at least once a year (except for foreign companies). It takes place in the established manner no earlier than 9 months and no later than 12 months after the date the certificate was issued.

Need expert help?

If you represent a domestic manufacturer or a pharmacy chain and have further questions about implementing GxP and ISO, get in touch with our specialists.

Agency address
BioPharma City
Support phone
1833

Send a request