Quality & compliance excellence in pharmaceuticals
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Quality can be defined in several ways including conformance to specifications, fitness for use, and value for price paid. It is judged based on factors like performance, reliability, and support services provided. Pharmaceutical products have higher quality standards and more regulations compared to consumer goods due to their intended use and potential risks. Ensuring compliance with various quality guidelines is important for patient safety and involves establishing quality systems, policies, procedures, documentation, and ongoing assessments like audits and corrective actions. Non-compliance can result in issues like complaints, recalls, and regulatory actions.
Quality & compliance excellence in pharmaceuticals
- 1. Presented by, Anvita Jadhav M.Pharm (IP) Sem I
- 2. What is Quality It can be defined in different ways Conformance to specifications measures how well the product or service meets the targets and tolerances determined by its designers. Fitness for use focuses on how well the product performs its intended function or use. Value for price paid is a definition of quality that consumers often use for product or service usefulness. Support services provided are often how the quality of a product or service is judged. A psychological criterion is a subjective definition that focuses on the judgmental evaluation of what constitutes product or service quality.
- 4. Difference between Pharmaceutical Product & Consumer Goods Pharmaceutical Product Consumer Goods Development • 2 – 3 years Payer • Customer Regulation • Low level of regulation Development • 10 – 15 years Payer • Mostly patient Regulation • Highly regulated
- 5. Sterile Product These products are by design required to be free from living micro organisms, pyrogens, & unacceptable particulate matter. Therefore it has more regulations than non sterile product In addition to non sterile product quality guidelines there are other procedures such as – Sterilization, Aseptic processing and also Premises Regulations, Equipments etc.
- 6. Guidelines of the Pharmaceutical Quality WHO Guidelines FDA Guidelines ICH Guidelines
- 8. Facilities & Equipment Equipment must be located, designed, constructed, adapted, and maintained to suit the operations to be carried out. Guidelines given by WHO Volume 2: good manufacturing practices and inspection (Quality Assurance of Pharmaceuticals), 13.1 to 13.13 US FDA: 21 CFR Part 211.63, 211.105, 211. 68, 211.72, 211.182 Schedule M: 11.1 – 11.5
- 9. Material The main objective of a pharmaceutical plant is to produce finished products for patients use from a combination of materials (starting and packaging). Guidelines given by WHO Volume 2: good manufacturing practices and inspection (Quality Assurance of Pharmaceuticals) 14.1 to 14.46 US FDA: 21 CFR Part 211 Schedule M: 10.1 – 10.10, 13.1 -13.6,
- 10. Production Production operations must follow clearly defined procedures in accordance with manufacturing and marketing authorizations, with the objective of obtaining products of the requisite quality. Guidelines given by WHO Volume 2: good manufacturing practices and inspection (Quality Assurance of Pharmaceuticals) 16.1 to 16.35 US FDA: 21 CFR Part 211 Schedule M: 8.1, 8.2, 9.1 – 9.5, 10.2, 24.1 – 24.3
- 11. Packaging & labeling All operations, including filling and labeling, that a bulk product has to undergo in order to become a finished product. Labels applied to containers, equipment or premises should be clear, unambiguous and in the company’s agreed format. Guidelines given by WHO Volume 2: good manufacturing practices and inspection (Quality Assurance of Pharmaceuticals) US FDA: 21 CFR Part 211
- 12. Laboratory Controls It is concerned with the organizational process and the conditions under which laboratory studies are planned, performed, monitored, recorded, and reported. Guidelines given by: FDA: 21 CFR 58 WHO: handbook of GLP
- 13. Clinical Practices Various regulations are involved clinical trials involving human subjects. Guidelines include protection of human rights as a subject in clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. Guidelines given by WHO: Handbook for Good clinical practice ICH guidelines Schedule Y
- 14. General Practices Recently Applied in the Pharmaceutical Industry Quality risk management Quality by design Corrective action and preventive actions Total quality management
- 15. The basic meaning focuses on target populations of regulation, the extent to which they comply with regulation, and why they do so. Compliance Fulfillment/ Conformity
- 16. Compliance encourages- Ethical behavior Fosters the right values Instills a culture of integrity
- 17. Regulatory Compliance The regulatory authorities are empowered to issue and enforce regulations for the manufacture of pharmaceutical products . Individual pharmaceutical companies produce a set of internal guidelines, rules, and policies to implement the regulation imposed by the regulatory authorities. Regulatory compliance applied to statements
- 18. Compliance Program to review policies & procedures through which industry complies with the various regulations program to prevent & detect violations of the regulation.
- 19. Strategies to achieve Compliance 1 • Creating an Environment that Supports Compliance 2 • Making Compliance Part of Everyone's Job. 3 • Empowering the Regulatory Affairs/Quality Assurance Function 4 • Employ the Appropriate Skills to Obtain Cooperation 5 • Educating Other Departments. 6 • Selling the Benefits of Quality and Compliance. 7 • Using Internal Audits Effectively. 8 • Reviewing and Reporting Quality and Compliance Data. 9 • Explaining the Consequences of Noncompliance.
- 20. Quality Policies The ISO 9000 requires quality policies to ensure that executive management has established system for quality. Quality policies define numerous systems as well as executive management’s commitment to quality.
- 21. Purpose & intent of quality policies Quality policies help industries to improve their internal compliance & total quality system. By instituting & adhering to quality policies, management obtains employees commitment to quality system. The formulation of individual quality policies should include the involved groups, depending on the placement of responsibilities within the individual organization.
- 22. Format & content of individual quality policies Executive management will probably determine who writes & edits the individual quality policies. Policies should contain minimal information on specific procedure & detailed information about structure, responsibility, & review. Definitions within policies are important to ensure that all parties are speaking the same language & are understanding. The policy should define the responsibilities of individual department implementing the policy & should ensure that adequate resources & structure exist for successful implementation.
- 23. Validation Pharmaceutical validation can be defined as a documented program, which provides a high degree of assurance that a specific process will consistently produce, a product meeting its pre- determined specifications & quality attributes
- 24. Advantages of validation Reduction of quality costs Process optimization Assurance of quality Safety
- 25. CAPA – Compliance Tool CAPA is corrective and preventive action Corrective action: Action to eliminate the cause of a detected nonconformity or other undesirable situation. Preventive action: Action to eliminate the cause of a potential nonconformity or other undesirable potential situation.
- 26. CAPA Process Identification Impact / Risk Assessment Immediate Action Root Cause Investigation Conclusion and Quality Decision Action Plan Implementation and Follow-up
- 27. Documentation Document is a piece of written, typed, printed or electronic matter that provides information or evidence. In each case, key sections of the documents are examined for compliance.
- 28. Documentation is essential- To define the specifications/procedures for all materials and methods of manufacture control. To ensure that all personnel concerned with manufacturing know what to do and when to do it. To ensure that authorized persons have all the information necessary to decide whether or not to release a batch of a drug for sale. To ensure the existence of documented evidence, traceability and to provide records and an audit trail that will permit investigation. To ensure the availability of the data needed for validation, review and statistical analysis.
- 29. Categories of documents Specification (e.g. raw material, packaging material, intermediate, finished product) Procedures (e.g. SOPs, STPs, process packaging instruction) Records & Reports Master Documents (e.g. MPCR, calibration master plan, site master file etc.) Lists (e.g. certified vendors, employees, equipment, process rooms)
- 30. Cost of Quality Compliance Cost of Quality Compliance Quality control costs Prevention costs Costs of preparing and implementing a quality plan. Appraisal costs Costs of testing, evaluating, and inspecting quality Quality failure costs Internal failure costs Costs of scrap, rework, and material losses. External failure costs Costs of failure at customer site, including returns, repairs, and recalls.
- 31. Effects of non compliance Complaints & adverse effects: Complaints about product is an indicator of the product quality, & also about the expectation of the consumer from the product. Recall of the product: A distributed product can be called back for various reasons. Manufacturer or FDA officials found out that the product is substandard.
- 32. Case Study The U.S. Food and Drug Administration had notified (on 23/1/2014) Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products. The FDA’s inspection on Jan. 11, 2014, identified significant CGMP violations. These included Toansa staff retesting raw materials, intermediate drug products, and finished API after those items failed analytical testing and specifications, in order to produce acceptable findings, and subsequently not reporting or investigating these failures.
- 33. Reasons for Non compliance 1. Lack of Regulatory Knowledge Requirements are too complex to know and understand. People cannot comply with regulations if they do not understand what is required.
- 34. 2 Lack of willingness towards compliance Compliance is too costly Overly legalistic regulation Failure to monitor Deterrence failure.
- 35. 3. Lack of ability to achieve compliance Failures of administrative capacity Desired outcomes cannot be achieved
- 36. Quality Audit Auditors are typical part of regulatory compliance for examine the data trail to determine whether company policies and procedures are followed. It has different categories – 1) Internal audits 2) External audits 3) Regulatory audits
- 37. Percentage of compliance: 100% compliance: When the auditor is fully satisfied with the compliance by the auditee by conforming that the auditee meets all the requirements specified in the specific clause 100% non compliance: When the auditor finds the requirements of the specific clause in not all complied with by the auditee. Partial compliance: When the auditor finds that the auditee has not fully compiled but only part compliance is observed.
- 38. Compliance classifications (according to US FDA) NAI – (No Action Indication) No objectionable conditions or practices were found during the inspection VAI – (Voluntary Actions Indicated) Objectionable conditions were found and documented but objectionable conditions do not meet the threshold for regulatory action OAI – (Official FDA Action Indicated) Regulatory violence is observed
- 39. Conclusion Quality & safety should be priority of any pharmaceutical industry. Quality can be achieved by the compliance excellence with the regulations. Compliance program should be there to study regulation & to implement them in best manner. It is the responsibility of everyone.
- 40. Reference: Bhaskar Mazumder, Sanjib Bhattacharya and Abhishek Yadav, Total Quality Management in Pharmaceuticals: A Review, International Journal of PharmTech Research, Vol.3, No.1, Pg. No. 365-375, Jan-Mar 2011. Sumit Kumar, Deepika Tanwar, Nageen Arora, The Role of Regulatory GMP Audit in Pharmaceutical Companies, International Journal of Research and Development in Pharmacy and Life Sciences, Vol. 2, No.4, Pg. No. 493-498, June - July, 2013. Reham M. Haleem, Maissa Y. Salem, Faten A. Fatahallah, Laila E. Abdelfattah, Quality in the Pharmaceutical Industry – A Literature Review, Saudi Pharmaceutical Journal, 2014. Julie Fishera, Arantza Aldeaa, René Banares-Alcantara, A Compliance Management System for the Pharmaceutical Industry, 18th European Symposium on Computer Aided Process Engineering – ESCAPE 18, 2008. Achieving Quality and Compliance Excellence in Pharmaceuticals, Editor Madhu Raju Saghee, Business Horizons, 2012. U.S. Pharmaceuticals, Compliance and Ethics Code of Conduct, Bristol-Myers Squibb Company, January 1, 2009.
- 41. Nancy Singer and Richard DeRisio, Optimizing Regulatory Compliance: Nine Strategies for Success, Compliance-Alliance LLC and Kinetic Concepts Inc., Medical Device and Diagnostic Industry, 2005. Chapter 2 Compliance Failures, Reducing the Risk of Policy Failure: Challenges for Regulatory Compliance, Organization for Economic Co-operation and Development, 2000. Ms. Marlise Gyger, CAPA (Corrective Actions and Preventive Actions), Quality and GMP, June 2012. James E. Carter, Quality Policies – Key to GMP compliance, Pharmaceutical Technology, October 1998. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm382736.htm Quality Assurance of Pharmaceuticals, Good Manufacturing Practices & Inspection, World Health Organization, Volume 2, Second Edition, 2007. Manohar A. Potdar, cGMP for Pharmaceuticals, PharmMed Press, 2012.