Meeting daily compliance in PharmaOperations

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1 Meeting daily compliance in PharmaOperations SKMF Spring Event 2012 Dr. Peter Hess

2 Themenübersicht Compliance Framework GMP Activities and compliance documentation in a production plant Compliance preconditions «The way» to compliance Intangible assets and value creation The missink link

Compliance preconditions «The way» to compliance

3 Pharma Compliance in the Press Reuters, Dec 6, 2011: FDA cites violations at three Novartis plants (Reuters) -Drug regulators cited Novartis AG for "significant violations" of manufacturing regulations at its three generic drug plants in the United States and Canada, several of which were repeat offenses. "We are concerned that your firm lacks process understanding to consistently manufacture", FDA wrote in the letter dated November 18. US department of Health & Services/FDA; Jan : Novartis is voluntarily recalling all lots of two products / Novartis commitment to quality Novartis Consumer Health, Inc. (NCH) announced today that it is voluntarily recalling all lots of select bottle packaging configurations of Excedrin and NoDoz products because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets. The Novartis Group is fully committed to ensuring the quality, safety and integrity of its products. All Novartis Group companies have a clear commitment to patients and Health Authorities to ensure high quality standards for all our products and services. Pharma Manufacturing Newsletter February 6, 2012: FDA report shows deep problems at closed Novartis Consumer Health plant. Novartis has set aside $120 million to address shortcomings at the plant and CEO Joseph Jimenez has told the investment community he is confident the plant will reopen mid-year.

"We are concerned that your firm lacks process understanding to consistently manufacture", FDA wrote in the letter dated November 18.

4 Compliance Framework in the Pharma Industry Ultimate goals of compliance: Safeguarding the health of the patient as well as producing good quality medicine, medical devices or active pharmaceutical products. cgmp (CurrentGood Manufacturing Practice): Main mandatory regulation for Pharma Industry anchored in the US federal Food, Drug, and Cosmetic (FD&C) Act and EudraLex Volume 4 in EU. "GMP" -A set of principles and procedures which, when followed by manufacturers for therapeutic goods, helps ensure that the products manufactured will have the required quality. A basic tenet of cgmp is that quality must be built into each batch of product during all stages of the manufacturing process. cgmp is that part of Quality Assurance aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use Compliance Monitoring & Enforcement: Inspections performed by national Regulatory Agencies like CH: Swissmedic, US: FDA, EU: DG Health & Consumers). Regulatory agencies are authorized to conduct unannounced inspections at any time the firms are open for business.

"GMP" -A set of principles and procedures which, when followed by manufacturers for therapeutic goods, helps ensure that the products manufactured will have the required quality.

5 GMP covers. ALLaspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Documents: Detailed, written procedures are essential for each process that could affect the quality of the finished product. Document Management: There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process -every time a product is made. Quality management system (QMS): Each company has to create own individual QMS which integrates cgmp requeirements but covers and integrates manyother (national) regulations, quidelines, internal policies. Qualification requirements ( ): Each person engaged or responsible for supervising in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Management approach: «The parameters and requirements to achieve compliance are given, let s do it «How do companies manage all that know-how Dr. Hess Interim How can Management all employees know at any time what and how to do Umfassende Kompetenz Responsibilities in Logistik und Produktion and

Document Management: There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process -every time a product is made.

6 Compliance Management Systems But: is that all.?

7 Overview activities in production plant Synthesis of final Product (API) : Several chemical stages required Products are manufactured in campaigns with multiple product lines configured to operate simultaneously. Parallel to the production: cleaning (product change), maintenance (repair, qualification, calibration). Summary: Dozens of different activities take place at the same time. A single stage SM1 IP1 SM2 API KI IP2 SM3 Handling Loading Process Work Up Isolation Sampling dispensing weighing of materials Solvents reagents intermediates chemical reaction step quench evaporation filtration extraction/ phase separation crystallisation filtration centrifugation drying milling sieving blending

Summary: Dozens of different activities take place at the same time.

8 Compliance: Overview important documents Regulated Areas Activities Documentation Buildings Infrastructure Process Equipment Control Systems Documentation Hygiene Manufacturing Utilities Tank Farm Warehouse QC Personel Security & Safety Process work Monitoring Cleaning Validation Calibration Qualification Sampling Staff Training Policies SOP Specifications Master Formula Record Batch MR Manuals Master plans/ files Validation protocols Forms and Formats Records Policies SOP Specifications MFR (Master Formula Record) Batch MR Manuals Master plans/ files Validation protocols Forms Policies SOP Specifications Master Formula Record Batch MR Manuals Master plans/ files Validation protocols Forms and Formats Records How can all employees know at any time what and how to do?

MR Manuals Master plans/ files Validation protocols Forms and Formats Records Policies SOP Specifications MFR (Master Formula Record) Batch MR Manuals Master plans/ files Validation protocols

9 Compliance Preconditions Novartis non-compliance?? GMP Compliance Compliance happens all the time, everywhere with every action: How can a plant manager guarantee and account for compliance relying on many Individuals? How to achieve compliance? Zero Error Culture Operational Excellence Something missing? Experience, Further learning Training on the job, SOP s, Practical GMP-raining GMP Theory, Company Guidelines, Education All management & staff levels Willngness Ability Knowledge Information

account for compliance relying on many Individuals? How to achieve compliance?

10 The «way» to compliance «Complience Rules» «The Way» Enforcement? Empowerment? Control? Trust? «The Goal»???

11 The «way» to compliance «Complience Rules» «The Way»?

12 The «way» to compliance «Complience Rules» «The Way»?

13 The «way» to compliance «Complience Rules» «The Way»?

14 Intangible assets and value creation Goal of Knowledge Management*) «A systematic approach to find, understand, share and use knowledge to cretae value» Pharmaceutical industry Knowledge based organizations with focus on operational excellence (= processes, quality & costs) use best practice by sharing knowledge Individual / intangible Assets = The true foundation of value creation are the intangible assets of the companies = Knowledge and Abilities of the managers, middle managers and frontline employees Leadership Willingness and Motivation Value Creation The ability to craete value depends not on written proceders and quiedelines, but on the willingens and motivation of individuals to focus on their daily work, to reach their daily goals and all compliance requierements *) Carla O'dell, C. Jackson Grayson, If Only We Knew What We Know, pioneers in Knowledge Management

intangible assets of the companies = Knowledge and Abilities of the managers, middle managers and frontline employees Leadership Willingness and Motivation Value Creation The ability to craete value

15 Summary: The missing link The ability to craete value depends not on written proceders and quiedelines, but on the willingness of individuals to focus on their daily work, to reach their daily goals and all compliance requierements GMP Compliance Zero Defect Culture Operational Excellence Skills, Behavior, Cultur Experience, Learning Training on the job, SOP s, Practical Training The ultimate driver for business success i.e. compliance is to transform knowledge and ability into willingness and motivation of each individual and his performance Motivation Ability Knowledge Company Guidelines, Education, GMP Theory, Information

16 The most ancient and simple compliance approach! Epicurus, BC, is one of the well known writers of antiquity. The central point of his thinking was linked to the question: On what relies the happiness of the wise man? Epicurus replies (fully in the meaning of GMPcompliance): The wise man arranges his life according to rules to relieve him from of fear, pain and desire

The central point of his thinking was linked to the question: On what relies the happiness of

17 Vielen Dank! Fragen?

MeriCal Quality Profile

MeriCal Quality Profile January 5, 2015 Dear Valued Customer, Since the implementation of new federal regulations, MeriCal Inc. has received a large volume of questionnaires and surveys regarding our services and procedures.