Quality Management

• Documented processes assure quality of products and services for APIs at Aceto Pharma GmbH according to Part II of the EU GMP guidelines ICH Q7A).
• Quality Unit independent from product and sales management
• Supplier qualification system
• Full traceability of products and individual batches; corresponding documents are retained and available for 10 years
• Quality assurance agreements upon request
• Steady improvement of the quality management systems
• Own laboratory and having co-operation with accredited external laboratories

Official Permission GMP

An import permission for Active Pharmaceutical Ingredients (APIs) of animal origin in accordance with section 72 of the German Drug Law (AMG) has been granted more than 10 years ago and has been extended in December 2008 to include APIs of microbial origin. Aceto complies with GMP regulations for importers and distributors of APIs.

Official Permission GDP

A Wholesale Permission for human and veterinary medicinal products according to section 52a of the German Drug Law (AMG) has been granted by the responsible German authority in May 2005. Aceto operates in compliance with EU guideline 94/C63/03 (Good Distribution Practice).

• Suitable and superintended warehouses for all distributed product
• Sampling of products under laminar flow (class 100)
• Separate area under lock and key for rejected products
• Physical separation of active pharmaceutical ingredients and fine chemicals
• Transport and handling under adequate conditions
• Continuous temperature and humidity monitoring in all warehouses
• Cool storage area 2 - 8°C for temperature sensitive products
• Pest control measures in the warehouses
• Avoidance of contamination
• First in First Out (FIFO) stock rotation system

Support for our Customers

It is Acetos policy to provide full technical and regulatory support side by side with our customers.

• Competent, experienced personnel with degrees in pharmacy and chemistry takes care of technical aspects of projects GMP audits by Aceto auditors with industry experience
• Review of drug master files, technical packages, site master files and similar documentation
• Selection of suitable partners for each individual project
• Evaluation of patent status for products and processes
• Regulatory intelligence: Steady monitoring of regulatory environment (ICH, CPMP, CVMP, WHO, PIC/S guidelines, HACCP, REACH)
• Audits of suppliers

Vendor Support

• Consulting services for suppliers
• Support to producers in preparing Drug Master Files (CTD format) and Application Dossiers for Certificates of Suitability
• Writing of Quality Overall Summaries on DMFs and Application Dossiers for CoS
• Assistance in answering questions from health authorities
• Improvement of working safety
• Regulatory intelligence: Steady monitoring of regulatory environment (ICH, CPMP, CVMP, WHO, PIC/S guidelines, HACCP, REACH)

Strict Compliance

Our goal is compliance with all Health, Safety, Transport and Environmental Regulations 100% of the time.

• Establishing Material Safety Data Sheets for all products inhouse
• Trained and examined safety advisers for road (ADR) and air (IATA) transportation
• Permission to store dangerous goods with good capacities
• Approval for storage of materials from water endangering classes 1 to 3
• Warehouses in compliance with EU and national environmental legislation
• Proper waste disposal of rejected or expired materials
• Compliance with all import and export regulations (e.g. dual use, GÜG, ...)
• Licence for narcotics