QUALITY AT APACE



Apace has a commitment to meet the quality and compliance needs of our customers. Apace follows Current Good Manufacturing Practices (cGMP), we meet FDA standards for parts 210 and 211 of 21CFR, and is licensed by the Kentucky Board of Pharmacy. Our standard operating procedures ensure that the highest quality products are delivered to customers on a consistent basis.

Apace Packaging adheres to state and federal regulations, and has been awarded Verified-Accredited Wholesale Distributors (VAWD) accreditation. List of VAWD-Accredited Facilities

The quality of your product begins with the training of the individuals responsible for production and Quality oversight. Apace personnel train constantly to ensure your product is packaged in compliance with cGMP guidelines.  Our talented staff are accurate, efficient and positive from the beginning to the end. Some of our processes are highlighted below.

Batch Records - Batch production details are recorded for each production run.

Deviations - Apace controls and documents any activity that alters an established process.

Change Control - Our manufacturing processes are clearly defined and controlled. Critical processes are validated to ensure consistency and compliance. Any changes to a process are evaluated and validated as necessary.

Document Control - All documentation at Apace is created, approved and maintained in an accurate and controlled fashion. Access control and auditing is maintained at all times.

Equipment Validation - Our equipment has been fully-validated to consistently perform within specified tolerances.

Cleaning Validation - All residues are removed to predetermined levels to ensure the quality of the next product is not compromised by waste from the previous product.

Preventative Maintenance - Scheduled activities are performed on all equipment to ensure proper operation..

 


Click here for photos of the Quality Department.