Premises and Equipment

Premises and equipment - suitability, layout, maintenance, qualification and validation 

Documentation - procedures, specifications, retention of records, electronic data 

Production - follow procedures, record deviations, prevent mix-up, validate processes 

Quality control - responsibility, review test results and production records, retain samples 

Work contracted out - contract clearly defining responsibilities, subject to GMP inspections 

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Quality Management Personnel Premises and Equipment Documentation Production Quality Control Contract Manufacture and Analysis Complaints and Product Recall Self Inspection... 

Good manufacturing practice (GMP) comprises that part of quality assurance which is aimed at ensuring that a product is consistently manufactured to a quality appropriate to its intended use. GMP requires that (i) the manufacturing process is fully defined before it is commenced and (ii) the necessary facilities are provided. In practice, this means that personnel must be adequately trained, suitable premises and equipment employed, correct materials used, approved procedures adopted, suitable storage and transport facilities available and appropriate records made. 

The chapter detailing premises and equipment describes similar obvious principles, such as ... 

The recent amendment in November 2008 to the drugs and cosmetic rules (II) includes a new Schedule L-1, which covers the Good Laboratory Practices and Requirements of Premises and Equipments, primarily for laboratories that support manufacture. Despite such specific emphasis of its applicability, the details of GLP requirements are in general alignment with those of the OECD, USFDA, USEPA, etc. 

Premises and equipment Documentation Production Quality control... 

Correspondences in EU GMP Code In the EU GMP code [15] issues related to organization and personnel are mainly covered in Chapter 2 (Personnel) and partly in Chapters 3 (Premises and Equipment), 5 (Production), and 6 (Quality Control). Correspondences to regulation 211.22 are covered in Subchapters 2.6,2.7,6.1, and... 

European Medicines Evaluation Agency (EMEA) (2003), Good Manufacturing Practices, Chapter 3 Premise and equipment, EMEA. 

Due to the inherent variability of animal cell-based systems, in-process control and strict adherence to GMP are of critical importance for obtaining quality products. Carefully planned facilities, together with bioreactor design and in-process control systems, determine product quality at feasible manufacturing costs. The regulatory agencies (EC, 1998a CFR, 2003) clearly state that the premises and equipment must follow GMP standards. 

For personnel working with radiopharmaceuticals, training and qualification should cover general principles of GMP and radiation protection. This includes also personnel in charge of cleaning premises and equipment used for this type of production. All manufacturing operations should be carried out under the responsibility of a QP with additional competence in radiation protection. 

In order to manufacture a medicinal product, the applicant must have available technical supervision and suitable premises and equipment that have the characteristics defined in the appropriate legislation. 

The contract partner should have adequate premises and equipment for the production of herbal medicines according to GMP. Validated methods should be applied for cleaning the equipment and premises carefully before using them to produce different herbal medicinal, food or cosmetic products. In the case of raw materials used for producing food, it is realistic to require manufacturing departments to be separated from those where the plant raw material will be cut or powdered for use in the preparation of medicines. 

It is essential that the premises and equipment to be used during concurrent validation have been previously qualified. 

If certain products are to be produced on a campaign basis, the layout and design of the premises and equipment shall permit effective decontamination by fumigation, where necessary, as well as cleaning and sanitizing after the production campaign. 

Premises and equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out Their layout and design must aim to minimise the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build up of dust or dirt and, in general, any adverse effect on the quality of products. 

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