Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) cover a wide range of operational issues relating to the manufacturing environment e.g.

• Quality Management
• Personnel
• Buildings and Facilities
• Equipment,
• Documentation and Records
• Materials Management
• Production and In-Process Controls
• Packaging and Labelling
• Storage and Distribution
• Laboratory Controls
• Validation
• Change Controls

The general principles are considered in numerous guidance documents at both national and international level e.g. ICH, EMEA, FDA.

Compliance with these practices in producing biopharmaceuticals and other biological products, including API, ancillary and finished products, for late stage clinical and commercial use is a legal requirement in most national regulatory systems.

Recent directives also consider minimising risks from early stage clinical trial product. The new directives, requiring  product to be produced according to GMP, is increasing the burden on early stage companies and research groups to assure GMP manufacturing capacity and experience in producing product.

Biotecnol outsources and manages the manufacture of their own and client’s products, for all stages of clinical trials and commercial use, with the services of Contract Manufacturing Organisations (CMO) and Contract Analytical Laboratories (CAL) with proven capabilities in GMP/GLP standards of operation.

Processes have been developed and transferred into client’s manufacturing facilities and third party CMOs. With this experience Biotecnol can effect a rapid and successful transfer of a process to ensure that product is available in appropriate time  for whatever stage of development.

A dedicated and knowledgeable project manager assures continuing and effective planning, co-ordination and communication between all parties, at all levels, throughout the project.

CMO / CAL Selection

A suitable CMO/CAL is identified early and a close relationship is developed,  at both the commercial and technical level,  to ensure the efficiency and success of the project. more

Technology Transfer

The process  coming from the labs / pilot plant and entering the GMP environment is effectively designed to facilitate rapid implementation. more

Documentation

Specific documentation is written in finalising the transfer of the process and analytics. more

Manufacture

As manufacture proceeds through clinical stages I and II continuing developments that may be necessary are tested and analysed. more