Bruce lect

MANAGEMENT OF QUALITY IN HEALTHCARE: 

MANAGEMENT OF QUALITY IN HEALTHCARE BACKGROUND Late 1960s - the drug Thalidomide caused severe limb deformities in utero drug not adequately trialled to provide evidence of safety ensuring therapeutic agents, diagnostic tests and reagents meet the standards required cannot be left to chance

UK GOVERNMENT ACTION IN RESPONSE TO THALIDOMIDE: 

UK GOVERNMENT ACTION IN RESPONSE TO THALIDOMIDE Medicines Act 1968 Guide to Good Pharmaceutical Manufacturing Practice significant increase in regulation over time, now also initiated by EC

INCREASING LEGISLATION AND REGULATORY CONTROL: 

INCREASING LEGISLATION AND REGULATORY CONTROL 1984 first BCSH Guideline 1985 anti - HIV screening (Oct) 1987 85/374/EEC Consumer Protection/ Product Liability (The Consumer Protection Act 1987) Product Liability 1988 1988 RCPath Accreditation study 1989 89/381/EEC European Self Sufficiency (Blood Components/Products) 1989 Guidelines for the UKBTS Rev’93;’97;2000; 01 1989 EEC Guide to GMP for Medicinal Products, rev ‘92; ‘97.

INCREASING LEGISLATION AND REGULATORY CONTROL: 

INCREASING LEGISLATION AND REGULATORY CONTROL 1990 NHS and Community Care Act Removal of Crown Immunity (licensing) Apr ‘91 1991 91/356/EEC Guide to GMP for Medicinal Products 1991 anti - HCV screening (Sept) 1992 CPA (UK) Ltd registered 1992 annex 13 to EC guide to GMP for Medicinal Products incorporates human blood/plasma

INCREASING LEGISLATIVE AND REGULATORY CONTROL: 

INCREASING LEGISLATIVE AND REGULATORY CONTROL 1992 92/42/EEC Harmonised EU standard for medical devices (eg blood packs) 1995 EC commitment to harmonising BT stds. 1996 CPMP ( US FDA) IM Ig screened for HCV RNA by PCR 1996 EC Colloquium on Blood Safety, Rome 1996 EC Colloquium on Blood Safety, Adare, Ire. 1996 SHOT scheme established 1997 CPMP promoting PCR (HCV) testing of all plasma for fractionation by 01 Apr 98 etc. ie regulations become ever more stringent

KEY AIMS FOR REGULATING QUALITY IN HEALTHCARE: 

KEY AIMS FOR REGULATING QUALITY IN HEALTHCARE setting quality standards checking for compliance vs standards eradicating unsafe practice delivery of safe and effective healthcare updating standards to deliver continuous improvement

PROBLEMS WITH THE REGULATORY PROCESS 1: 

PROBLEMS WITH THE REGULATORY PROCESS 1 INEFFECTIVE REGULATORY SYSTEMS 1. eg US FDA - Center for Biologicals Evaluation and Research (CBER) full GMP evaluations seldom performed cannot issue warning letters to government agencies - but oversee military establishments !! often have not examined operations closely have not always documented what was examined have avoided taking regulatory action BLOOD SUPPLY SAFETY Hearing before the Sub Committee on Oversight and Investigations One Hundred Third Congress July 28 1993

PROBLEMS WITH THE REGULATORY PROCESS 2 THE UB PLASMA FIASCO: 

PROBLEMS WITH THE REGULATORY PROCESS 2 THE UB PLASMA FIASCO in Nov 1993, there was worldwide recall of plasma originating from UB Plasma in Koblenz due to financial pressure some samples were pooled for HIV testing, some were untested at least 3 patients were infected with HIV 6 years earlier, a UB employee shared his concerns with German Health Officials - no action was taken UB “evaded” the PEI system by continually submitting requests for release of small batches of product on a case-by-case basis.

REGULATIONS CANNOT GUARANTEE QUALITY: 

REGULATIONS CANNOT GUARANTEE QUALITY based on inspection - an imperfect tool generates a culture of compliance we need a much broader approach to quality based on: prevention through good management designing quality into processes continuous improvement partnerships with staff, customers and suppliers the use of appropriate “tools” eg SPC; JIT etc but never overlooking the importance of GMP PLEASE REMEMBER YOU HAVE RESPONSIBILITIES!

Slide10: 

DEFINITION OF QUALITY ASSURANCE “The sum total of all arrangements made with the object of ensuring that medicinal products are of the quality required for their intended use” Rules and Guidance for Pharmaceutical Manufacturers, HMSO 1997

Slide11: 

DEFINITION OF GOOD MANUFACTURING PRACTICE “Good manufacturing practice (GMP) is that part of QA which ensures that products are consistently produced and controlled to the quality standards required for their intended use.” Rules and Guidance for Pharmaceutical Manufacturers, HMSO 1997

Slide12: 

DEFINITION OF QUALITY CONTROL “Quality control is part of GMP. It is concerned with…... .. and the organisational entities which have responsibility for delivering these functions.” …..sampling programmes, specifications for raw materials, consumables and finished products, testing, documentation, release procedures, analytical equipment and good (laboratory) practice……..

Slide13: 

BASIC PRINCIPLES OF QUALITY ASSURANCE quality, safety and effectiveness are built into products and services quality cannot be inspected or tested into a product or service each step in the process must be controlled to the defined quality standards our products are medicines and services to support patient care so our standards must be high, every step of every process must be performed as instructed

Slide14: 

KEY ELEMENTS OF GMP quality management personnel premises and equipment documentation production quality control contract manufacture and analysis complaints and recall self inspection Rules and Guidance for Pharmaceutical Manufacturers, HMSO 1997

Slide15: 

“SPECIFICATION” FOR A QUALITY SYSTEM satisfies regulatory/accreditation requirements is “owned” and understood by the workforce is an integral part of how everyone works is focused on GMP, continuous improvement, customer satisfaction and improved supplier performance ensures the delivery of high quality products and services provides key management information everyone’s commitment and contribution are crucial

Slide16: 

QUALITY SYSTEM PERSONNEL Head of Production and Head of Quality Assurance must be independent of each other adequate numbers of personnel with the necessary qualifications and experience responsibilities of all staff defined in job descriptions awareness of the principles of GMP relevant initial and ongoing training, including hygiene which must be documented

Slide17: 

RULES ABOUT CLEANLINESS AND THE PREVENTION OF CONTAMINATION always maintain high standards of personal cleanliness always wash your hands after visiting the toilet always wear protective clothing as instructed never handle products or chemicals directly by hand. If it is necessary to do so, wear the gloves provided report infections, colds, coughs, stomach upsets, cuts or grazes, to your supervisor

Slide18: 

RULES ABOUT CLEANLINESS AND THE PREVENTION OF CONTAMINATION eating, drinking, chewing or smoking are not permitted in production and stores areas, nor should food, drink, sweets, smoking materials and personal medicines ever be taken into these areas always check that your work-place and surrounds are clean and tidy if you have cleaning procedures to carry out, always follow the instructions EXACTLY

Slide19: 

always check that equipment and containers have been properly cleaned before you use them. It is YOUR responsibility always work with care, to avoid creating dust or spillages ALWAYS be on the alert for possible sources of contamination. If you see anything that looks as if it might cause contamination, report it immediately RULES ABOUT CLEANLINESS AND THE PREVENTION OF CONTAMINATION

Slide20: 

PREMISES Good Building Design adequate space for all functions ie: production packaging QC storage refreshments toilets adequate changing facilities

Slide21: 

PREMISES Good Building Design adequate security suitable equipment - easy to clean well designed services suitable air handling/ air quality system adequate labeling of areas, supplies etc

Slide22: 

QUALITY SYSTEM PREMISES AND EQUIPMENT premises and equipment should be located, designed, constructed, adapted and maintained to support the production of high quality medicines the layout of premises and location of equipment should be designed to avoid mix up/contamination during production premises and equipment should be carefully maintained, regularly cleaned and disinfected

Slide23: 

SNBTS QUALITY SYSTEM PREMISES AND EQUIPMENT lighting, temperature, humidity and ventilation should not adversely affect the products or manufacturing equipment measures should be taken to protect against the entry of insects and other animals measures should be taken to prevent the entry of unauthorised personnel

EQUIPMENT: 

EQUIPMENT adequately specified before purchase validated correctly prior to use (IQ; OQ; PQ) SOP for operation, cleaning etc regular calibration, maintenance regular revalidation log book to record maintenance, faults etc

Slide25: 

QUALITY SYSTEM DOCUMENTATION to be clear about what we are going to do ie it defines the quality system, prevents errors from spoken communication thereby introducing formality and the basis for control to ensure consistency of manufacture and of service provision THE REASONS FOR DOCUMENTATION

Slide26: 

QUALITY SYSTEM DOCUMENTATION to confirm that we have done what was required – and have done so correctly to keep records about what we have done to enable us to investigate problems, errors, defects, complaints etc and to determine corrective and preventative action THE REASONS FOR DOCUMENTATION

Slide27: 

QUALITY SYSTEM DOCUMENTATION to be of any value, documentation must be accurate, unambiguous & easily understood. documentation errors remain one of the single largest problem areas we encounter. please take the time and care needed to ensure you always complete paperwork properly. PLEASE TAKE CARE WITH DOCUMENTATION

Slide28: 

QUALITY SYSTEM DOCUMENTATION to be of any value, documentation must be accurate, unambiguous & easily understood. documentation errors remain one of the single largest problem areas we encounter. please take the time and care needed to ensure you always complete paperwork properly. PLEASE TAKE CARE WITH DOCUMENTATION

Slide29: 

records are about current events, not history nor the future! a person entering a second check signature or initials is confirming that he or she actually saw what was done (for example, a weighing) and has personally checked that everything was correct (product, material, batch, quantity, reading etc). QUALITY SYSTEM DOCUMENTATION RULES ABOUT MAKING RECORDS

Slide30: 

it is NOT good enough, and it could be very dangerous, to just "trust your mate" to have got it right, and write in second-check initials/signatures at the end of the day. these too should be entered as things happen, indeed, when they have been SEEN to happen. QUALITY SYSTEM DOCUMENTATION RULES ABOUT MAKING RECORDS

Slide31: 

records should always be NEAT and CLEAR records should be made in black ink, never pencil never use correction fluid (AKA liquid paper or Tipp-Ex) QUALITY SYSTEM DOCUMENTATION RULES ABOUT MAKING RECORDS

Slide32: 

if you do make a mistake, do not obliterate it or cover it up. Cross it out neatly (so that it can still be read), make the correction and sign/initial and add the date (with any explanation necessary). If necessary, show it to a supervisor. QUALITY SYSTEM DOCUMENTATION RULES ABOUT MAKING RECORDS

Slide33: 

SELF INSPECTION (AUDIT) PROGRAMME “A planned, independent investigation of selected elements of a quality assurance system to collect objective evidence that the system has been implemented, is effective and is being complied with.” AUDIT

Slide34: 

PRODUCTION 1 RAW MATERIALS vendor approval via a suitable method raw material purchasing specification each batch of raw material tested as required raw material held in quarantine until released by QA rejected material clearly identified

Slide35: 

PRODUCTION 2 BATCH MANUFACTURE effective process design should ensure: prevention of cross contamination batch identity throughout process critical steps validated and monitored consistent product quality consistent yield assurance of product sterility

Slide36: 

PRODUCTION 3 PRODUCT STORAGE product at different stages of manufacture clearly separated and labeled appropriately rejected material clearly labeled and stored in quarantine stored at the appropriate temperature temp monitored, action if limits exceeded appropriate reviews prior to release

Slide37: 

PRODUCTION 4 PACKAGING of key importance. Packaging errors account for most product recalls stringent control of preprinted labels and boxes reconciliation of packaging materials effective “line clearance” procedures ensure superceded packaging is withdrawn

Slide38: 

COMPLAINTS AND RECALLS full traceability of all issues systems ensure recording of: product defects adverse reactions general complaints system to ensure rapid recall of any product subsequently found to be defective

Slide39: 

QUALITY CONTROL 1 Validation of assay methods all assay methods must be comprehensively validated accuracy linearity limit of detection limit of quantitation precision specificity sensitivity

Slide40: 

QUALITY CONTROL 2 Implementation of assay methods all assay methods must be appropriately implemented documented method validated equipment calibrated equipment suitable reagents adequate internal and external controls data reviewed by trained staff statistical analysis of assay performance

Slide41: 

THE COST OF QUALITY PREVENTION plan to do it right APPRAISAL FAILURE check after it is done do it wrong then do it over COST DO IT RIGHT FIRST TIME, EVERY TIME

Slide42: 

GMP AND QUALITY quality is not the responsibility of one person or department quality is everyone’s responsibility ultimately, the quality of a product or service depends on the quality of those producing it!

Slide43: 

THE TEN BASIC RULES OF GMP be sure you have the correct written instructions before any job is started always follow those instructions EXACTLY with no "cutting corners". (ASK if you don't understand) ensure that the correct materials are being used

Slide44: 

THE TEN BASIC RULES OF GMP ensure that the correct equipment is being used, that it is CLEAN, and appropriately calibrated work in a manner that will prevent contamination and mix up always guard against labelling errors always work accurately and precisely

Slide45: 

THE TEN BASIC RULES OF GMP keep things (including yourself!) clean and tidy always be on the look out for mistakes, errors and bad practices and report them immediately ("covering up" could cost lives!) make clear, accurate records of what has been done, including any checks carried out.