The High Tech Manufacturer

Abdoul Hamid Derra (Autor)

Buch | Softcover

216 Seiten

2025
Our Knowledge Publishing (Verlag)
978-620-7-82332-1 (ISBN)

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These good practices come from part II of the European guide to good manufacturing practices for medicinal products for human and veterinary use, itself taken from the ICH Q7A guide developed by the international harmonization conference (ICH). These good practices are intended to provide a guide to good manufacturing practices (GMP) for the manufacture of active substances under an appropriate quality management system. They are also intended to provide assistance in ensuring that active substances comply with the quality and purity requirements they claim or are expected to have. In these good practices, "Manufacturing" includes all operations of reception of materials, production, packaging, repackaging, labeling, relabeling, quality control, release, destocking and distribution of active substances as well as any associated controls. The term "Must" indicates the recommendations that are expected to be followed, unless it can be demonstrated that they are not applicable, are supplemented by specific GMP guidelines, or are superseded by other measures.

Abdoul Hamid Derra - Information systems engineer, entrepreneur, researcher, developer of strategic studies, educational advisor, mother-child health, nutritionist.

Erscheinungsdatum	01.06.2025
Sprache	englisch
Maße	152 x 229 mm
Gewicht	295 g
Themenwelt	Medizin / Pharmazie ► Allgemeines / Lexika
Themenwelt	Medizin / Pharmazie ► Gesundheitsfachberufe
Schlagworte	Acceptance Criteria • Active Substance • Batch • Batch Number • Biocharge • Calibration • Computerized System • Computer system • Contamination • Contract Manufacturer • Control Date • Critical • Cross Contamination • Deviation • Drug • Expected Yield • expiration date • Impurity • Impurity Profile • In-process Control • Intermediate • Manufacturing • Mother Juice • Packaging Articles • Pharmaceutical Substance • Primary Reference Substance • Procedure • Process Additives • Process Control • Production • Qualification • Quality assurance • quality control • Quality Units • quarantine • raw material • Secondary Reference Substance • Sign • signature • Solvent • Specification • Specific Reprocessing • Standard Reprocessing • Starting Material of Active Substance • Theoretical Yield • Validation • Validation Protocol
ISBN-10	620-7-82332-X / 620782332X
ISBN-13	978-620-7-82332-1 / 9786207823321
Zustand	Neuware