Information & Training. | Product & Process Validation.
Pharmaceutical GMP Training.
FDA ensures the quality of drug products by carefully monitoring drug manufacturers’ compliance with its current Good Manufacturing Practice (CGMP) regulations. The cGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.
The approval process for new and generic drug marketing applications includes a review of the manufacturer’s compliance with the cGMPs. FDA assessors and investigators determine whether the firm has the necessary facilities, equipment, and ability to manufacture the drug it intends to market.
The regulations enable a common understanding of the regulatory process by describing the requirements to be followed by drug manufacturers, applicants, and FDA.
21 CFR Part 314 For FDA approval to market a new drug.
21 CFR Part 210. Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs.
21 CFR Part 211. Current Good Manufacturing Practice for Finished Pharmaceuticals.21 CFR Part 212. Current Good Manufacturing Practice for Positron Emission Tomography Drugs.
21 CFR Part 600. Biological Products: General.
Pharmaceutical GMP Training. FDA CFR’s section 211.25 Personnel Qualifications.Part 211 – Current GMP’s for Finished Pharmaceuticals, Subpart B – Organization and Personnel, Section 211.25 – Personnel qualifications.
(a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee’s functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
(b) Each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess.
(c) There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product.
Pharmaceutical GMP Training. Section 211.34 Consultants.Consultants advising on the manufacture, processing, packing, or holding of drug products shall have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Records shall be maintained stating the name, address, and qualifications of any consultants and the type of service they provide.
EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Part 1, Chapter 2: Personnel
Section 2.3People in responsible positions should have specific duties recorded in written job descriptions and adequate authority to carry out their responsibilities. Their duties may be delegated to designated deputies of a satisfactory qualification level. There should be no gaps or unexplained overlaps in the responsibilities of those personnel concerned with the application of Good Manufacturing Practice.
Pharmaceutical GMP Training. Section 2.6 The “Qualified Person”.The duties of the Qualified Person(s) are described in Article 51 of Directive 2001/83/EC, and can be summarized as follows:
a) for medicinal products manufactured within the European Union, a Qualified Person must ensure that each batch has been manufactured and checked in compliance with the laws in force in that Member State and in accordance with the requirements of the marketing authorization;
(b) in the case of medicinal products coming from third countries, irrespective of whether the product has been manufactured in the European Union a Qualified Person must ensure that each production batch has undergone in a Member State a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorization. The Qualified Person must certify in a register or equivalent document, as operations are carried out and before any release, that each production batch satisfies the provisions of Article 51.
The persons responsible for these duties must meet the qualification requirements laid down in Article 493 of the same Directive, they shall be permanently and continuously at the disposal of the holder of the Manufacturing Authorization to carry out their responsibilities.
Section 2.10 Training:The manufacturer should provide training for all the personnel whose duties take them into production and storage areas or into control laboratories (including the technical, maintenance and cleaning personnel), and for other personnel whose activities could affect the quality of the product.
2.11 Besides the basic training on the theory and practice of the quality management system and Good Manufacturing Practice, newly recruited personnel should receive training appropriate to the duties assigned to them. Continuing training should also be given, and its practical effectiveness should be periodically assessed. Training programmes should be available, approved by either the head of Production or the head of Quality Control, as appropriate. Training records should be kept.
2.12 Personnel working in areas where contamination is a hazard, e.g. clean areas or areas where highly active, toxic, infectious or sensitizing materials are handled, should be given specific training.
Information & Training.
Product and Process Validation.
- Validation versus Verification
- Integration of Risk into Validation
- Validation Gap Analysis
- Implementing a Validation Process (IQ, OQ, PQ)
- The Validation Master Plan (VMP)
- Validation during the Design processes
- Software Validation
- Cleaning Validation
- Cleaning Process Sampling and Test Methods
- Documentation Management for Validation compliance
- Equipment, Component, Material and Facility Validation
- Implementation of a re-Validation process
- Protocol Reporting
- Implementation of the Audit process to assure Validation effectiveness
- How to ensure that Validation activity is appropriately documented, reviewed and aligned with requirements.
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The Rules Governing Medicinal Products in the European Union