GxP support and consulting
Following the rules and recommendations of GxP allows you to successfully cope with the high level of complexity of technological processes and the influence of a strict regulatory system
GxP support and consulting
GxP (Good Practice) is a system for ensuring the quality of medicines, recognized throughout the world. It covers every stage of the drug’s life cycle: from the beginning of its development, production and storage, to receipt by the end consumer.
WE WILL JOIN YOUR TEAM AND PROVIDE SUPPORT IN PART OF:
GxP (Good Practice) is a system for ensuring the quality of medicines, recognized throughout the world. It covers every stage of the drug’s life cycle: from the beginning of its development, production and storage, to receipt by the end consumer.
- Support of projects of any complexity
- Development of Normative Documents and Regulations
- Assessment of the possibility of combining the production of medicines
- Assessment of technical and economic indicators and investment assessment of the project
- Implementation of computerized systems
- Documentation
Implementation of GPP standards for pharmacies
- Development of SOPs (Standard Operating Procedures)
- Consultations on organizing areas and processes in a pharmacy.
- Employee training
- Pharmacy audit
Implementation of GDP standards for distributors
We provide a range of services for pharmaceutical distributors to ensure compliance with the requirements of good distribution practice. This ensures that consistent quality management systems are in place throughout the supply chain.
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Development of SOPs (Standard Operating Procedures) -
Validation and Qualification -
Consultations on organizing zones and processes in a warehouse -
Training -
Thermal mapping of a warehouse -
Transportation of medicines -
Organization of corporate trainings -
Company audit according to GxP standards -
Evaluation of Suppliers and Customers
Organization of Corporate Trainings on GxP
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Warehouse employee training -
Preparation of video materials for employees -
Training of the Authorized Person for Quality System Control -
Creation of an online training platform
Validation and Qualification
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Validation of critical processes -
Qualification of critical equipment -
Consultation on equipment installation -
Validation for Process Improvement
5 main steps to prepare a client for GDP
Determining the current level
of compliance
with GDP requirements
of compliance
with GDP requirements
Identification of inconsistencies and approval, corrective
actions
actions
Development of SOPs (Standard Operating Procedures), instructions and forms
Training and implementation
of a quality management system
of a quality management system
Preparing a package of documents
and submitting an application
and submitting an application
Passing the Inspection
OUR CLIENTS
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LLC «Tar Pharm Alliance»Umarxodjayev Aziz Bosidovich - Director
Thanks to the consultation of LeanPharma LLC on the implementation of GDP standards, our company received a License for the sale of drugs and a GDP Certificate. We are very grateful to the LeanPharma LLC team, who worked hard with our team to establish processes according to the GDP standard. -
LLC "GENERATION PHARMA SERVICES”JUMAYEVA MALIKAXONIM ALISHER QIZI - Director.
We received the GDP Certificate thanks to the consulting services of LeanPharma LLC. We really liked the company’s specialists, who were always in touch and completed all their services in a timely manner. Moreover, after receiving comments from the inspection, we worked together to eliminate inconsistencies -
LLC «INSO FARM DELUXE»OGAY YELENA LAZAREVNA - Director.
We are grateful to LeanPharma LLC for introducing GDP standards into our company. We liked the process of supporting the company from the beginning of the project to completion, as well as supporting the company until it received a GDP certificate. We would like to cooperate with the company “LeanPharma” LLC in the future. -
LLC «SOFORA MED»Umarov Sh.Sh. - Director
They received GDP and License -
LLC «VITRUM MED LINE»Uzakova Mahbuba Inoyatovna - Director
They received a GDP License.
OUR CONTACTS
Address: Tashkent, Mirzo-Ulugbek district. M. Yusuf street, 1A
Phone: +99890 948 45 30
Mail: ibragimov@leanpharma.uz
Phone: +99890 948 45 30
Mail: ibragimov@leanpharma.uz
