Problems for the implementation of investments The Ongoing pharmaceuticals projects should ensure compliance with the GMP requirements, which is a specific condition as distinct from other types of investments. Regular reviews for compliance with the GMP guidelines should be done on the early stages. They should be conducted in parallel with the design. It is very important that all discrepancies have been previously discovered so that the cost of repairing them will be relatively low. During the implementation phase of the investment the Project Manager should implement qualification procedures and / or engage people who are trained in Type: Direct Impact (D) or Indirect (I)
Normally GMP Important
Documentation and Commissioning
Purified Water and WFI
D
Yes
Enhanced
CIP/COP Systems • Final • Pre-Final
D I
Yes No
Enhanced GEP
Clean Steam
D
Yes
Enhanced
Nitrogen and other Process Gasses
D
Yes
Enhanced
Instrument Air
I
No
GEP (=Good Engineering Practice)
Depends on use
Yes In Classified Manuf. Areas
Depends on Application and Area Classification
No
No
GEP
Process Heating/Cooling
I
No
GEP
Process Vacuum
D
Yes
Enhanced
Controlled Potable Water
D
Yes
Enhanced
Non-Process Potable Water
I
No
GEP
Depends on use
Depends on use
GEP Depends on use
I
No
GEP
System
HVAC Breathing Air
Mechanical Seal Fluids Chilled Water
Polish industry
To lead in such a way our investment it is necessary to implement our management risk program of analysis (in accordance with the guidelines ICH Q9). This program allows for early identification of possible threats, and consequently focuses on its elimination (for example, through appropriate action eligibility).
qualifications. It happens sometimes, that the investment of a new pharmaceutical production is led by a person with low awareness of the principles of the GMP. In fact, the Construction Manager should oversee the entire time the quality of the work and executive companies must be aware of their role in the building process of a pharmaceutical plant or an object. To fully ensure the quality of work regulations during the implementation it is indicated for the participation of a team with expertise in matters related to both the technical acceptance and subsequent qualification object. This team is able to identify and minimize the risks associated with the implementation of the pharmaceutical investment since the beginning of its life. The participation of the supervise team to the investment for compliance with the GMP can be implemented in two ways. The first solution, much cheaper for the Investor, is participation of a trained person in preparation of the User Specification Requirements (URS). The specifications should contain a list of necessary documents, the proposed regulations and test, which must be supplied and manufactured for the particular system installation, in order to achieve compliance with the GMP. Such specifications should be transferred directly to person responsible for the execution of the construction. However, the first solution may prove insufficient, and only the seemingly cheaper, since the implementation of the User Specification Requirements by the subcontractors of the particular systems and installation is not always coincide with the expectations of the authors of this specification, and may entail the need for subsequent amendments
Source: ISPE Baseline Guide Biopharmaceuticals, Industry Review Draft December 2002
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