General Flashcards
What is the link between QMS and GMP?
2004.94.EC - Art 6: MFG shall establisha and implement and effective QMS + management particpation
What are the essential elements of an effective QMS?
People: Adequate number Clear structure Sufficient training Personnel hygeine Plant/Equipment: Design + locate + construct with operation in mind Layout min risk Secure Qualified + PPM Premises + equipment - cleaning Poilcies and procedures: Change controls Customer complaints Recall Deviation Reporting Procedure Risk management and Rx Ax Audit and self inspection Vendor assurance MFG processes: Tech transfer Define: Master formular + Spec + SOP + work instructions Validated Monitored - IPC Maintained Recorded, reviewed and approved QC: Suitable premises and people Sampling procedure Ref samples Validated test methods Results reporting Stability testing Warehouse + distribution Product secure + protected Controlled storage conditions Traceability maintained throughout
What are the eight quality management principles defined in ISO 9000:2000?
- Customer focus: understand customers’ need
- Leadership: establish unity of purpose and direction of the organisation
- invovlvement of people: of all level
- Process approach: manage activities as process
- System approach to management: interrelated processes as system
- Continual improvement:
- Factual approach to decision making: data and information driven
- Mutually beneficial supplier relationships
What is meant by the Product Lifecycle?
Complete life of a medicinal product through the various stages of design, development, manufacture and distribution from the day of its conception
What are the parts of a QMS?
Management support system: People management: organogram + training Documentation management: SOP Validation and Qualification: euquipment + process Control of contrators and suppliers Systme managing complaints and recall Monitoring and feedback mechanisms Self inspection
Batch release system or final approval system
The design and development of the product and process
MFG syste and production controls
Packaging system and controls
Maintenance and monitroing of the facilities, utilities and equipment
Lab and analytical testing system
Control fo materials and suppliers
Distribution controls
What are the two main principles of ICH Q9 QRM?
The evaluation of risk to quality should be based on sci knowledge and ultimately link to the protection of the pt
The level of effort, formality and documentation of QRM process hsoudl be commensurate with the level of risk
What are the steps of QRM?
Rx ID
Rx analysis
Rx evaluation
What are the product types that require dedicated facilites?
Penicillin and cephalosporins
What are the product types that require clear separation?
Other antibiotics Cytotoxics Steroids and hormones Raio isotopes Narcotics - i.e. CDs Other potent or sensitising drugs
How can the products be separated?
Campaign working
Procedural controls
Use of validated cleaning procedures - can’t validate manual cleaning - need verification everytime
Identify the key MFG stages that require separate segregated facilities?
Receipt, sampling and quarantine of RM Quarantine and sampling of intermediates and finished products Holding of rejected goods Storage of released materials Storage of packaging materials Equipment washing Ingredient weighing MFG and processing operations Packaging operations Lab testing
What does the term “design space” mean?
Established range of process parameters that has been demonstrated to provide assurance of quality
Working within the design space is not regarded as change
What are the main considerations during Tech Transfer?
Clearly define responsibilities of development group and other - who is responsible for what
Communication: - how is the key information transferred
What criteria to use to meausre effectiveness of the transfer
Describe a framework of validation management?
Overall corporate validation policy
VMP for each site, owned and managed by the validation steering committee on that site
A validation project must have a validation plan - could be part of another doc if small projects / more than one if big projects
Process / Equipment / Systems list - “to do” list
What should a validation policy include?
Corporate wide scope Commitment to validate Responsibilities Maintaining the validated states Periodic review Documentation Processes/equipment out of scope
What should a VMP include?
Site specific scope
Describe what to validate (how to validate is in SOPs)
Defines validation lifecycle
Roles and responsibilities i.e. steering committee
Change management during a validation project
Define vlidation review processand frequency
What are the roles of a Validation Steering Committee?
Site wide responsibilities - local management team ensure vlaidtaion is done
Should include: PM, QC, Engineering, IT and validation
develop and maintain VMP
define local validation methodology
Set validation priorities
review progress
provide resources and resolve resource conflicts
approve changes to the methodology to be used
provide training
meet monthly
provide minutes of meetings for interested parties
What should a VP contain?
define the scope of the validation project
ID the validation team and its role - who does what
Validation strategy: why do it this way
Roles and responsibilities
Timeline optional
What are the EU classifications of recall?
Class 1: potentially life threatening or could cause a serious risk to health
Class 2: could cause illness or mistretment but not Class I
Class 3: may not pose a significant hazard to health
Class 4: The MHRA also issues “Caution in Use” Notices which are called a Class 4 Drug Alerts,
where there is no threat to patients or no serious defect likely to impair product use or
efficacy.These are generally used for minor defects in packaging or other printed materials
What does ICHQ8 aim to deliver?
Q8 Pharm development
Product quality and performance achieved and assured by design of effective MFG process
Product spec based on mechanistic understanding of how formulation and process factors impact product performance
An ability to affect cont improvement and continous real tiem assurance of quality
What is ICH Q10?
Q10: QMS
describe one approach to developing an effective pharmaceutical quality sys - based on GMP and iso
facilitate innovationg and cont improvement throughout the product lifecycle
embraces both Q8 and Q9 and seeks to promote knowledge managmeent and continual improvement of products, processes
Things to remember
Water for irrigation sterile but 0.5 iu for endotoxins
When sterile question ask re parametric release
List for audit
Qms- cc deviation Personnel- training and competence Premises and equipment Documentation Production Quality Control Batch release and QP training Material handling returns and Shipping Complaints, recalls
