GMP API Manufacturing Facility

GMP API Manufacturing

“Impressive combination of capabilities in one location.”

As a GMP Active Pharmaceutical Ingredient Manufacturing facility, our Pharmaceutical Contract Manufacturing services can support the Drug Discovery process through API Synthesis for all the stages of clinical trials. We conduct GMP manufacturing of API's from small volumes to multi kilos. Our capabilities in cGMP synthesis, analysis and Aseptic Fill are regularly used to support the pharmaceutical and biopharmaceutical manufacturing industry.

Custom Synthesis of Small Molecules and biopolymers is carried out in our state-of-the-art cGMP API manufacturing facility. Our clean suites are rated at Class 10,000, whereas most API suites are either unrated or are only at the Class 100,000 level.

We are currently involved in the small scale cGMP contract manufacturing of active pharmaceutical ingredients in many drug classes. Some of the current API manufacturing originated as custom synthesis and others as Contract Research. When processes for contract research are developed/improved to allow API synthesis for our clients, we ensure that the solvents used conform to ICH guidelines.

All API synthesis is supported by our chemistry expertise, GMP compliance and extensive quality control. We are currently manufacturing sterile medical devices and commercial products under GMP. We have manufactured many products for clinical trials (Phase I, II, and III).

Sterile API Manufacturing

Production of sterile APIs is a specialized area which is currently underserved in the pharmaceutical industry. Dalton’s GMP Aseptic Filling capabilities include aseptic filling and capping of liquid-in-vial injectable drugs, aseptic filling and stoppering of liquid prefilled syringes, and aseptic filling and capping of powders. We follow the guidelines for the manufacture of sterile APIs set out by the task force from the Active Pharmaceuticals Ingredients Committee of the European Chemical Industry Council (CEFIC) available at apic.cefic.org. Dalton’s Quality System complies with FDA and Health Canada regulations as well as with the ICH guidelines.

GMP Audit Experience

We are as serious about regulatory compliance as our API Synthesis customers. Their auditors consistently tell us that, of all of the GMP facilities they have audited, Dalton is in the top 25%. Some quotes are below:

“I was most impressed by your operation from both a GMP and regulatory perspective.”
- GMP Compliance Manager, Corporate Quality

“I was particularly impressed with the knowledge of the staff that were present during the visit
and the continuous improvement approach....”
- Director of Quality and QP

“Dalton Pharma Services, Toronto, was found to be in general compliance with equivalent standards of GMP to those defined in EU Directive2003/94/EC Annex 1 and 2001/20/EC appropriate for the manufacture and testing of...”
- Director of Quality and QP

“There is a [very] knowledgeable team at Dalton. The level of GMP compliance of the facility
was considered satisfactory for the continued manufacture of API and for
Drug Products to be imported to EU.”
- CEO, QP

“....Dalton Pharma Services had a well functioning and effective quality system
....All involved personnel gave a very competent impression.”
- ISO/GMP Lead Auditor

API Synthesis: Validation

In a regulated industry, special care must be taken to ensure all equipment and processes are performing to specifications. Deviations can have unpredictable and sometimes devastating results. Therefore, we pay special attention to equipment qualification and process validation to provide full regulatory compliance for our API manufacturing clients. We follow the strictest guidelines, perform the most rigorous testing and execute studies in a timely fashion to ensure that your product is of the highest quality when it reaches its destination.

Dalton has capabilities to develop, create and execute validation protocols and studies required for your products and equipment in accordance with current Guidelines (HPFBI, FDA, EP, ICH, WHO) and acceptable formats (prospective, retrospective and concurrent). These include process validation, cleaning validation, aseptic processing, terminal sterilization, environmental control, IQ/OQ/PQ/PV and utility qualifications. Statistical analysis and decision making analysis are also part of our service.

We stand by our products, which are manufactured to the highest quality standards. Learn more about our Custom Drug Synthesis products.

If what you are looking for is not on the list please contact us at 1-800-567-5060 or 416-661-2102 or email us and we will gladly meet your pharmaceutical contract manufacturing needs.