Quality Policy

A quality policy is a brief statement that aligns with your organization’s purpose and strategic direction, provides a framework for quality objectives, and includes a commitment to meet applicable requirements (ISO 9001, customer, statutory or regulatory) as well as to continually improve.

Quality Policy Component Requirements:

1. Quality Councils: Quality Councils shall be held to assure communication of key quality metrics. Quality Council activity shall be documented and reported to senior management at a frequency defined in supporting procedures.

2. Quality Risk Management (QRM): A Quality Risk Management process shall be implemented, performed and documented to assure risk assessment related to contamination of products, risk to safety of employees and ultimately risk to patients is addressed.

3. Site Master Files: Site Master Files shall be prepared by each site and shall contain specific information about the quality management policies and activities of the site, the production and/or quality control of pharmaceutical manufacturing operations carried out at the site

4. Validation Master Plan:  Validation of production-related processes shall be performed in facilities that are supported by suitable utilities according to approved procedures, so they will consistently yield products that meet pre-determined specifications and are validated in accordance with regulatory requirements.  Validation of analytical test methods, computer systems used in the manufacture and support of commercial products shall be performed.

5. Training: Personnel shall have a combination of education, training and experience to perform assigned functions.  At a minimum, training shall be documented and proficiency concerning performance of assigned tasks tested.

6. Change Control: A change control system shall be implemented that is supported by approved and maintained procedures where qualified representatives from appropriate disciplines review changes that might affect the validated status of facilities, systems, equipment or processes and determine need for action that would ensure and document the system is maintained in a validated state.

7. Complaints:  Quality Management shall develop and maintain a procedure describing the company requirements for processing Product Quality Complaints.  Each site shall have approved procedures in place that detail how to receive, process, investigate, close, manage records and trend complaints.  Provision shall be included in complaint procedures for timely escalation of critical complaints to top Quality Management to assure the recall process is engaged, if required. 

8. Incidences/Discrepancies/Non-conformances: These unexpected events from cGxP’s shall be identified, documented, assessed, investigated and closed in a timely manner according to approved procedures to the extent necessary to determine cause, impact on product and criticality. Metrics related to these events shall be captured and trending performed to support the Corrective and Preventive Action process.

9. Product Recalls: Drug Product Recall procedures shall be established to ensure recalls are executed properly and that all involved parties are responsive in case of an emergency.  Mock recalls shall be performed to challenge procedures on a periodic basis if an actual recall has not been performed for a twelvemonth period.

10. Corrective and Preventive Action (CAPA): At a minimum, the system shall include requirements for identification, evaluation, implementation, effectiveness monitoring, closure and documentation of the corrective and preventive action.  A tracking system shall be implemented to verify progress in completing CAPA activities such as effectiveness testing.

11. Product Quality Reviews: An organized and comprehensive evaluation of all production, analytical and Quality  data done at pre-defined frequencies to determine the appropriateness of product specifications, manufacturing instructions and control procedures, to verify the product manufactured is consistent over time and to confirm that the process, procedures  and product quality are in an adequate state of control and to identify actions to address adverse trends or issues found as a result of the annual review.

12. Documents and Records: A program shall be established that defines the responsibilities and processes for preparing, approving and maintaining cGxP documents and site SOPs to assure the documents are securely controlled and to assure document and data integrity.

13. Internal Audits: At a minimum, the procedure shall make provision for completion of an annual internal audit schedule to assure that all systems are covered on a frequency defined in the procedure.  Furthermore, provision shall be made to track and close all audit observations in a timely manner.  Status of Internal Audits and metrics concerning all observations, as well as progress related to closure of open findings, shall be reported to the Quality Council for follow-up, as required.

14. Regulatory Inspections: Each site shall establish approved procedures for accepting, preparing for, managing, responding to and follow-up related to cGxP system inspections by regulatory authorities to assure that these inspections are handled in a consistent and controlled manner.

15. Notification of Management: Quality Management shall develop and maintain a procedure for promptly alerting senior management of serious cGxP-related quality events that may affect not only prospective, but also marketed product(s). 

16. Regulatory reporting of changes related to product chemistry and manufacturing and notification of approval: Procedures shall be established for management of post-approval changes to related product applications of approved marketing authorizations and the notification of regulatory approval of the changes to assure regulatory compliance is maintained.

17. Notification to Competent Authority Regulatory Agencies: Procedures shall be established and maintained to assure that formal notification to health authorities occurs in a timely manner when a distributed batch fails to meet any of the specifications established in an application.  Potential field actions shall be evaluated and communicated in a timely manner.  Market alerts and recall decisions and strategies shall be implemented effectively according to established procedures.  All activities and communications associated with a market product field action or recall shall be executed and documented to assure compliance with applicable regulations.

18. New Product Introduction: Quality Assurance shall verify that approved procedures are in place to perform final confirmation to assure that product meets the registered and quality requirements prior to the initial release of product to the requesting market.  Procedures shall also be in place with provision for a Regulatory Affairs verification that assures the product requested by the Marketing Company and the product produced by the manufacturing site is registered with the desired countries and the approval to market has been received.

19. Resource Allocation and Management: Quality Management shall develop and maintain a system and supporting procedures to assure adequate resources are in place to meet compliance expectations

20. Assignment of Manufacturing and Expiration Dates to Drug Products and APIs: A procedure shall be implemented that clearly defines how manufacturing and expiration dates are determined for APIs and drug products.  Stability testing shall be required to serve as a basis for expiration dating initially and ongoing testing required to support the expiration period. 

21. Control of Outsourced Operations: At a minimum, requirements such as creation of quality agreements and their approval by Quality Assurance prior to engaging services such as Contract Manufacturing Organizations (CMOs) and Contract Testing Laboratories shall be included, as well as monitoring of performance by Supplier Quality Management contract service providers,

22. Licensing and Acquisition: A procedure shall be established to define the requirements and responsibilities of Quality Assurance to assure quality and compliance (including risk assessment) are addressed during the process of acquiring a new product, facility, technology, registration or process. 

23. Field Alerts:  Quality Management shall develop and maintain a procedure describing the Corporate and site processes for filing Field Alerts consistent with the time required by the FDA regulations (3 business days).

24. Labeling: There shall be a system to manage the design, preparation of the approved copy (text and graphics) and approval of product labeling material. There shall be also systems to receive, hold, sample, test, disposition, release, reconcile and destroy labeling material.  Label reconciliation shall be performed following approved procedures and against pre-established reconciliation limits with documented investigations and appropriate follow-up being launched whenever the reconciliation limits are not met.

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