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Pharmaceutical Quality System > PQS > Flashcards

PQS Flashcards

1
Q

What is the objective of a PQS

A

The Pharmaceutical Quality System is the sum of all the management arrangements made with the objective of managing the quality system and ensuring that the finished product, as delivered, will be fit for its intended use.

It is the effectiveness of the design and operation of the Quality System that should give a QP the confidence to certify product.

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2
Q

ICH Q10 defines a pharmaceutical quality system as

A

“A management system to direct and control a pharmaceutical company with regard to quality”

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3
Q

The key components of the Quality System include:

A

Quality Vision and Mission
* Policies and Procedures
* People management; including Organisational Structure, Education and Training
* Document Management
* Validation and Qualification
* Change and Deviation Management; including CAPA
* Monitoring and Feedback Mechanisms
* Batch Release

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4
Q

What is the QPs role in the PQS

A
  • Development
  • Implementation
  • Maintenance
  • and Review
    …of the quality system.

The QP should have an intimate understanding of the effectiveness of the Quality System.

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5
Q

How is the effectiveness of the PQS monitored

A

Assessment of Quality Systems
Assessment, or audit, is a prime mechanism by which a QP can judge the effectiveness of the quality management system.

Auditing and self-inspection should form part of management’s strategy to continually improve and prevent mistakes.

One key way for management and the QP to monitor the effectiveness of a quality system is to identify and trend ‘Key Performance Indicators’ (KPIs).

Quality management review

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6
Q

Typical KPIs for a pharmaceutical quality system include:

A
  • Recalls
  • Complaints
  • Product returns due to company errors
  • Out of Specification results
  • Rejected lots
  • BMR non-conformances
  • Deviations and investigations
  • Internal and external audits
  • Adherence to programme and findings
  • CAPA closeout
  • Batches reworked
  • APRs done on time
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7
Q

QPs must review trends in quality KPIs and ensure that

A

management are driving continual improvement in product, processes and systems.
When issues and problems arise QPs must ensure that management are made aware of the issue and that they then take appropriate action in a timely manner.

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8
Q

The main components of a quality system should be defined and applied to all parts of the business, such as:

A
  • Management Support Systems
    ➢ Quality vision and mission
    ➢ Policies and procedures
    ➢ Definition of Processes
    ➢ Quality review and improvement
  • People management: including organisational structure, education and training
  • Document management
  • Validation and qualification
  • Control of contractors and suppliers
  • Change and deviation management; including CAPA
  • System for managing customer feedback, e.g. complaints and recalls
  • Other monitoring and feedback mechanisms, e.g. in-process checks
  • Self-inspection
  • Batch release system or final approval system
  • The design and development of the product and process
  • The manufacturing system and production controls
  • Packaging system and controls
  • Maintenance and monitoring of the facilities, utilities and equipment
  • Laboratory and analytical testing system
  • Control of materials and suppliers
  • Distribution controls
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9
Q

The ‘lifecycle’ of a product includes:

A

Market research
* Development chemistry and pharmaceutics
* Toxicology studies
* Synthesis and purification
* Clinical trials
* Manufacture and dosage form (plus packaging and labelling)
* Validation and process control
* Ongoing stability testing and shelf life
* Storage and distribution
* Monitoring of the safety profile after marketing (PV)
* Product discontinuation

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10
Q

ICH Q10 (Pharmaceutical Quality System) defines 4 major lifecycle phases:

A

Pharmaceutical development
* Technology transfer
* Commercial manufacturing
* Product discontinuation

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11
Q

Change management stage gates

A

1.Propose Change
2.Risk Assessment
3.Approve/Reject Change
4.Plan and Implement
5.Review and Close-Out
6.Post Implementation Actions

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12
Q

Effectiveness verification methods

A

Audit, sampling, real-time review, trend analysis, post event review, periodic review, process confirmation

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13
Q

A large part of the materials management system is defined in Chapters 3 and 5 of EudraLex Volume 4 and in the Good Distribution Guidelines (2013/C 343/01)

What controls are available for People

A
  • Access control
  • Job descriptions/structure
  • Staffing resources (turnover, use of temps)
  • Cleaning team
  • Training
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14
Q

A large part of the materials management system is defined in Chapters 3 and 5 of EudraLex Volume 4 and in the Good Distribution Guidelines (2013/C 343/01)

What controls are available for Premises

A
  • BMS, limits, specs, monitored, controlled (heat, cool, humidity)
  • Outside storage areas for large tank farms etc.
  • Secure
  • Structure and fabric
  • Covered unloading
  • Housekeeping including high level
  • Pest control
  • Capacity
  • Alarms
  • Where is sampling performed?
  • Sampling environment and area classification
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15
Q

A large part of the materials management system is defined in Chapters 3 and 5 of EudraLex Volume 4 and in the Good Distribution Guidelines (2013/C 343/01)

What controls are available for Product

A
  • Adequate identification
  • Segregated
  • Control in place
  • Cold chain/controlled storage
  • Controlled drugs stored correctly
  • Printed components securely stored and transported
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16
Q

A large part of the materials management system is defined in Chapters 3 and 5 of EudraLex Volume 4 and in the Good Distribution Guidelines (2013/C 343/01)

What controls are available for Procedures

A
  • Validation/qualification of cold chain
  • Temp and RH mapping
  • Receipt procedures including handling temp controlled products and excursions
  • Goods in SOP
  • Handling reject material
  • Destruction of rejects, handling waste
  • SAP or equivalent stock control systems
  • Sampling procedures
  • Cleaning of storage areas and of sampling tools
  • Approved suppliers’ lists maintained
  • Dispensing/picking procedures
  • Labelling procedures
  • Status control systems
  • First in first out stock control
17
Q

A QAA consists of 3 parts, what are they?

A

The introduction defining the business relationship which exists between AZ and the entity.

The core agreement is to describe who clearly undertakes each step of the outsourced activity, for example subcontracting, materials, undertaking production, quality controls (including in-process controls, sampling and analysis), stability studies set down, analyses and releasing.

The associated side letter (when required) and appendices.

18
Q

Unexpected deviations

A

Annex 16 (section 3)
A QP may consider certifying a batch where there has been an unexpected deviation from the MA and/or GMP during the manufacturing / testing processes if certain criteria are met:
All registered specifications are met
The deviation must be thoroughly investigated and the root cause corrected.
This may require the submission of a variation to the MA for the continued manufacture of the product.
The impact of the deviation should be assessed in accordance with QRM principles and include the following:
Evaluation of the potential impact of the deviation on Q, S, E of the impacted batch and conclusion that the impact is negligible.
Consideration of the need to include the impacted batch in the ongoing stability programme.
In the case of biological medicinal products, consideration that any deviations from the approved process can have an unexpected impact on safety and efficacy.
Taking account that responsibilities may be shared between more than one QPs involved in the manufacture and control of a batch, the QP performing certification of a batch of medicinal product should be aware of and take into consideration any deviations which have the potential to impact compliance with GMP and/or compliance with the MA.

19
Q

Batch specific variations

A

MHRA Guidance
UK/GB only type of variation (also Ireland). Requires National Licence. No aligned process across EU  can’t use for CAP.
A BSV is a variation application to request agreement for a single or small number of batches of product to be released outside of the usual conditions of the MA.
Intended to be used rarely where an unexpected or unavoidable situation has arisen (for example a production problem) and approval is needed to maintain stock on the market, consequently such variations should only be submitted in exceptional circumstances.
In each case, the applicant should provide evidence that the quality, safety and efficacy of the product are unaffected by the deviation in the batch concerned.
Documented within QMS – deviation/change control.
BSV’s follow normal Type II timelines and fees.

20
Q

Importation of product

A

For change
-Change control with risk assessment
-Technology transfer
-Vendor approval inc. audits (QMS based)
-QTAs (R&R, communication / escalation inc. timelines)
-Accreditations/Licences (API: ISO9001 & ICH Q7, FP: EU GMP cert)
MRA countries except from EU GMP cert requirement
-Licence variation (MA: API supplier, manufacturing/testing/cert site)
-QP API declaration
-Stability (at least 6 months, 3 x batches of API)
-FMD requirements: excipient RAs, API to GMP/GDP, API registration
-Routinely receive copies of PQR
-Relevant procedures in QMS covering importation processes
For release – as per Annex 16
-Importation testing: On bulk in GB and in EU before certification
On bulk in EU (GB only)
If bulk manufactured in MRA country then no testing required
-CoA & CoC from third country sites – inc. deviations, changes, OOS
-Copies of batch documentation  full review on first 3 batches to ‘validate’ process  then simplified review with full annual review
-Supply chain mapping, GDP controls
-TSE status of materials
-Temp / humidity data for shipping and storage
-Safety features applied (if needed)
-Reference/retention samples available in GB & EU (if from 3rd country)
No MRA between GB & EU  reference samples needed in EU
-QP certification in GB and/or EU
-RPi check and SN decommissioned or not applied (EU to GB only supply)

Pharmaceutical Quality System (9 decks)

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