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Pharmaceutical Quality System (PQS)

Our PQS aligns with and complements our current business model and future business plans/growth while continuing to focus on regulatory compliance. Thus, our PQS supports our business from product development to compounding/market supply and through to product discontinuation. We envision our PQS to be an effective and integrated quality management system that is built upon the basic foundation of compliance to the cGMP’s.

Our PQS mandates an independent Quality Unit (QU) with clearly defined responsibilities.

Our QU at SCA Pharma has the authority to create, monitor, and implement a Quality System and it has specific responsibility for the following:

  • Ensuring that controls are implemented and completed satisfactorily during manufacturing operations
  • Ensuring that developed procedures and specifications are appropriate and followed
  • Approving or rejecting incoming materials, in-process materials, and finished compounded product
  • Reviewing production records and investigating any unexplained discrepancies
  • Final release of the finished compounded product to market

In addition, the QU at SCA Pharma is organizationally independent of all other functions at SCA Pharma, including Operations.

Our PQS incorporates the following:

Supplier Management

Supplier and material controls at SCA Pharma assure product quality and business/operational capability through close management of quality at source and at the beginning of our product lifecycle.

SCA Pharma ensures the suitability and competence of suppliers and associated materials using a defined supplier management system of audits, material evaluations, supplier qualification.

We constantly monitor and review supplier performance and we provide feedback to suppliers as part of our supplier management system.

Process and Product Quality Monitoring

SCA Pharma conducts formal Annual Product Reviews (APR’s) on each finished product and process. Through this mechanism potential trends are identified and addressed through our quality system.

CAPA (Corrective and Preventive Action)

SCA Pharma has a system to implement corrective and preventive actions following investigations for complaints, adverse events, product rejections, audits and regulatory inspection and findings or trends. CAPA’s may also arise from product and process monitoring and may be an outcome of Management Review.

If an adverse trend is identified, SCA Pharma’s CAPA system investigates the root cause of the trend and implements actions to course correct the trend and to minimize recurrence.

Change Management

At SCA Pharma, innovation, continuous improvement, output from our monitoring systems and CAPA, drive change. SCA pharma has a robust and effective change management system that provides detailed instructions for initiation, review and approval of additions or changes to our PQS and to validated systems and processes.

Within the change management system changes are approved prior to implementation following a thorough evaluation for potential impact on quality and validation status of critical systems.

Management Review

Management Review at SCA Pharma is our demonstrated commitment of leadership oversight of our PQS. We convene on a periodic basis to review our PQS metrics and the outputs of all product and process reviews that take place at the facility level. Our Management Review also reviews progress in our Continuous Improvement program and initiatives.

Environmental Controls

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 compounding and prompt action is taken to correct deviations to expected conditions. If a problem cannot be immediately corrected, compounding is stopped until corrected. Drug storage areas, incubators, and refrigerators are monitored for temperature and humidity through a similarly automated monitoring and alarm system.

Electronic Quality Management System

SCA Pharma utilizes the electronic MasterControl system to facilitate management of our GMP processes:

Training

MasterControl provides employees with the required training materials so that they may train and have completion of their training and associated competency assessments, documented.

Document Management

MasterControl enables the system of documentation control and management. It allows for organizing, tracking and updating GMP procedures electronically.

Investigations

MasterControl enables systematic and robust investigations and their timely completion when there is an occurrence that represents a deviation from expectations or when an out of specification result is generated during release or stability testing.

The systems currently supported by MasterControl and planned to be supported, are as follows:

  • Training
  • Document Management
  • Deviation Investigations
  • Out of Specification Investigations
  • Change Control
  • Corrective and Preventive Action
  • Customer Complaints (by end of 2020)
  • Environmental Excursions (by end of 2020)
  • Internal Audits (by end of 2020)
  • External Supplier Audits (by end of 2020)
  • Supplier Complaints (by end of 2020)

State of the Art Laboratories: SCA Pharma has state of the art in-house laboratories that support our global organization.

Chemistry Laboratory

The Chemistry Laboratory at our Windsor facility is responsible for developing and implementing robust analytical test methods that meet ICH validation criteria and that are stability-indicating. The laboratory conducts analytical release testing for each batch of finished product and full stability studies to support the product Beyond Use Date (BUD).

Our Chemistry Laboratory is equipped with:

  • High-Pressure Liquid Chromatography (HPLC)
  • Ultra High Pressure Liquid Chromatography (UPLC)
  • Liquid particle counters
  • Thermo and Caron stability chambers and refrigerators
  • Karl Fischer Titration
  • pH meter
  • Atomic Absorption

Microbiology Laboratory

Our Microbiology laboratories are equipped with state-of-the-art rapid technologies for sterility and endotoxin testing together with an automated microbial enumeration system. Microbial testing is performed on batches manufactured as part of a rigorous batch release process.

SCA Pharma’s  investment in rapid micro technology supports our commitment to deliver safe and effective medications  to patients, as quickly as possible.

In conjunction with our Environmental and Personnel Monitoring program, SCA Pharma also has the capability to perform in-house microbial identification using an automated mass spectrometry system. Our microbial identification program continuously assesses and trends any  microbial recoveries from within our classified areas.

Each laboratory is equipped with rapid microbiological technology, including:

  • SCANRDI Rapid Sterility Test
  • Endosafe-MCS System
  • Growth Direct Rapid Micro Testing
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