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Pharmaceutical Quality System (PQS)

SCA Pharma has a completely independent Quality unit that develops procedures to ensure adherence to current Good Manufacturing Practices (cGMP).

Our PQS is constantly evolving and changing to adhere to the latest requirements in the safest and most efficient ways possible. Our PQS incorporates the following:

Supplier Management

Supplier and material controls assuring product quality and business/operational capability through risk management.

This helps SCA Pharma understand the suitability and competence of suppliers to carry out the activity or provide the material using a defined supply chain of audits, material evaluations and qualification.

We constantly monitor and review performance and supply feedback as part of the supplier control lifecycle.

Change Controls

SCA pharma has a robust change control program that provides detailed instructions for initiation, review and approval of additions or changes to SCA validated systems.

Within the change control program, changes are approved prior to implementation following evaluation for potential impact on quality and validation requirements of critical systems.

CAPA (Corrective and Preventive Action)

If an adverse trend is identified, the SCA Pharma Corrective and Preventive Action (CAPA) system is utilized to investigate the root cause and implement corrective and preventive actions to resolve the discrepancy and minimize recurrence.

Deviation, Out of Specification (OOS)

SCA Pharma’s clean rooms are continuously monitored for pressure, humidity, and temperature through an automated monitoring and alarm system that is capable of detecting excursions.

Monitoring for pressure differentials, humidity, and temperature occur during sterile product production, and prompt action is taken to correct deviations to expected conditions. If a problem cannot be immediately corrected, CSP production is stopped until corrected. Drug storage areas, incubators, and refrigerators are monitored for temperature and humidity through a similar automated monitoring and alarm system.

Internal Audits

As part of cGMP guidance for 503B compounding facilities, SCA Pharma’s Quality team conducts periodic internal audits.

 

State of the Art Laboratories

In addition, SCA Pharma features State of the Art in-house Laboratories to support the entire quality organization. These include:

Chemistry Lab

Equipped with:

  • Ion Chromatography UPLC
  • Liquid particle counters
  • Thermo and Caron stability chambers and refrigerators
  • DI Water system
  • Baker fume hoods

The Chemistry Lab is responsible for conducting full stability and potency studies per lot.

Microbiology Lab

Responsible for Sterility Testing and Environmental Monitoring.

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