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.
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
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
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
1
Determining the current level
of compliance
with GDP requirements
of compliance
with GDP requirements
2
Identification of inconsistencies and approval, corrective
actions
actions
3
Development of SOPs (Standard Operating Procedures), instructions and forms
4
Training and implementation
of a quality management system
of a quality management system
5
Preparing a package of documents
and submitting an application
and submitting an application
6
Passing the Inspection
GMP Audit for the Foreign Manufacturing Companies
“Lean Pharma Consulting” LLC is pleased to provide the GMP Audit Services to the foreign manufacturing companies, which are planning to pass through GMP Audit from the Uzbekistan Pharmacy Agency. “Lean Pharma Consulting” LLC helps the foreign manufacturing companies to know the requirements of the Uzbekistan Pharmacy Agency and being prepared for the inspection. The consultant specialists of the company has more than 5 years’ experience in implementation of GxP standards in Uzbekistan and worked in “Center of Good Practices” SUE of Agency on Development of Uzbekistan Pharmaceutical Industry.
Assessment inspection on production lines.
Organizing a full inspection by checking production lines and all the documentations.
Developing the project of the manufacturing facility.
Checking the production scheme and consulting on the improvement.
OUR CLIENTS
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
