As a manufacturer and packager for some of the world's leading pharmaceutical companies, Span Packaging Services' Quality Assurance regularly undergoes comprehensive, exacting audits. An average of 24 customer audits per year helps provide continuous improvement to our procedures, systems and processes. This also ensures compliance with the most current regulations and customer specifications.

Our personnel know that "actions speak louder than words", so we daily demonstrate our belief in being honest, effective, and responsive. This attitude has helped us not only meet but exceed our customers' goals and expectations for decades.

Our award-winning Quality System includes:

• Validation Program Consisting of Cleaning Validation, IQ's, OQ's, PQ's, Manufacturing Process Validations, Packaging Process Validations, Test Method Validations and Test Method Transfer Validation.
• Generic protocols to provide a baseline (or customize as needed) for your product/company.
• Validated USP Purified Water System – with Ozonated Distribution Loop - used to make bulk batches; sampled and tested each day at point-of-use to assure USP water quality limits are met.
• Calibration Program for critical lab, manufacturing, packaging and facility equipment
• PM (Preventive Maintenance) Program for critical lab, manufacturing, packaging and facility equipment
• Retention Area for records and samples of raw materials, bulk and finished product lots in a secure, monitored, segregated location.
• Annual Drug Product Review Reports compiled for OTC drug products.
• Device Master Records maintained for Medical Device Products.
• Internal Audit program maintained.
• Audits of Contract Labs and Suppliers performed to assure continued compliance.
• Compressed air system sampled and tested.
• Monthly environmental sampling and testing of production environments.
• Management Reviews performed to assure continued improvement and awareness.
• Drug Products listed with FDA.  (Span is not required to be registed as a Medical Device Establishment or list Medical Devices with FDA since Span does not perform Distribution)
• MSDS, Hazardous Waste Disposal, and Monthly Pest Control programs in place.
• Employee training performed and maintained for GMP's, job-specific training and quality training.
• Incoming goods held in quarantine until inspected per established specifications, sampling and testing procedures by QA.
• QA Finished Product Inspection performed per applicable/specified ANSI Sampling Plan.
• QA Finished Product Lot Release to assure products meet established specifications prior to release.
• Systems and procedures to provide traceability in case of a Recall or investigation.
• CAPA (Corrective & Preventive Action) procedure in place to document and perform an investigation, provide Corrective Action(s) for an immediate incident, and provide Preventive Action(s) to assure the incident will not reoccur. Issues included in the CAPA system are as follows: Consumer Complaint Reports, Rework, Returned Goods, OOS, Rejected Materials, Supplier Issues, Customer Quality Issues.
• Action items tracked to completion and evaluated for effectiveness
• Where applicable, data compiled, put into charts, trended, and reviewed to monitor areas and implement actions as deemed appropriate.
• QA Document Control for maintenance of current P&P’s (Policies & Procedures).
• QA Technical Documents for maintenance of current Customer Specifications.