QUALIFICATIONS OF INVESTIGATING PERSONNEL
The persons concerned with investigations must be qualified by appropriate education. The responsibilities of the personnel are mentioned in writing. He should practice good sanitation and health habits and must practice hygienic activities ,should wear clean clothing and a protective apparel,such as head, face arm coverings which protect the APIs from contamination. Direct contact with APIs and smoking, eating and drinking should be avoided. Personnel suffering from infections or having open leisions are not allowed to engage in any activity that could adversely affect the API quality.
Regarding the building requirements,there should be the presence of well defined areas for :
Utilities like, proper ventilation,filtration and exhaust systems are must,besides these, water,containment,lighting,sewage and refuse complete the basic requirements of good manufacturing practices. validated computerized systems,calibration of testing equipments.,and equipment maintainence are the necessary accessories to maintain the quality of manufacturing practices.
The GMP guidelines define the controls and specifications for devices so that ,
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The devices are designed under a quality system to meet these specifications.
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The devices are manufactured under a quality system.
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The devices are correctly installed, checked and serviced.
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The quality data is analyzed to identify quality problems and complaints are processed.
This assures that medical devices are safe and effective for their intended use. The Food and Drug Administration (FDA) inspects the manufacturer operations and records and monitors the compliance with GMP requirements.
The most crucial part of GMP is the documentation of every aspect of the process involved with drug and medical device manufacture. If the documentation showing how the product was made and tested is not correct, then the product does not meet the required specification and is considered contaminated and can not be commercialized.
The equipments and procedures utilized for manufacturing and testing of medical devices must have been validated assuring that they can perform their purported functions.
GMP provides the required space for the manufacturers so that they can perform their functions without pressure and can find out better and convenient methods for their work while still working in compliance to GMP. These reliefs are in compliance to 21 CFR 820 sections such as:
- Flexibility: GMP specifies certain standards and procedures to maintain the quality systems but at the same time the manufacturer is also left free to adopt methods which prove to be more productive and safely in compliance to GMP standards simultaneously.This flexibility is allowed under 21CFR 820.180.
- Exemptions: There are certain establishments that are exempt from GMP requirements under certain FDA conditions such as:
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An exemption in response to a citizen's petition for exemption
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In the absence of a petition, FDA exempts the device and publishes the exemption in the Federal Register.
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When the device is exempted by FDA classification regulations published in the Federal Register and codified in 21 CFR 862 to 892
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The device is an intra-ocular lens (IOL) under an IDE and meets the requirements of the IDE regulation for IOL's (except for design controls 21 CFR 820.30).
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FDA may also launch a policy for non application of GMP requirements for certain devices although the devices may not have been exempted from GMP requirements
A point to be noted is that, the grant of exemption documents should always be kept ready and well maintained and must be shown during GMP inspection, verifying that the exemption has been granted
