Code of Practice and Annex 16 Flashcards
(21 cards)
What is the QP responsible for according to code of practice
The QP is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force where certification takes place.
WRT Code of Practice, what should QPs ensure is in place?
Adequate professional indemnity insurance arrangements are in place
What should QPs do with senior management
Show them the code of practice
In complicated supply chains with many QPs, what might you need
Separate QP/QP technical agreement defining responsibilities
How often should a QP be on site?
for a sufficient proportion of the working time to discharge their legal and professional duties.
The time spent on site should also allow the QP to both have effective oversight and to fulfil their other duties with respect to the PQS and delegated duties
If there’s more than one QP on site and they don’t agree, what should be done?
Pistols at dawn
They should know what the other is doing to avoid discrepancies in the first place
Discuss between QPs
Then senior management and poss their society for guidance
What do contract QPs need to do?
1) Written contract
2) Be on site enough – sufficient oversight and knowledge of site compliance
3) Be around for staff to ask questions and for regulatory audits and CA comms
4) Make sure the company will let them see whatever, wherever and/or whoever they need to certification
5) Know about any PQS issues
Who needs to review Technical Agreements
The QP
What’s important for remote certification
It needs to be in the PQS otherwise no go
What’s the deal with CPD?
Needs to be done to stay up to date with processes, equipment, regs and GXP updates
Records need to be kept and available for audit. May need submitting to RSC
What’s the deal with new dose forms or technologies to the QP
The QP needs formal training against a plan inc gap analysis - plan approved by senior management
What does a QP need to bring to attention of senior management
Batches that may need rejection or recall
Gaps in PQS wrt GMP rules
What can get you struck off?
Intentionally or unintentionally certifying a batch as fit for sale or supply without ensuring that the relevant tests and checks had been performed or not in compliance with either GMP or the Marketing Authorisation / PSF.
What’s the process of batch release in Annex 16
a) Checking the manufacture and testing of the batch as per processes
b) QP certification batch is per GMP and MA
c) Transfer to saleable stock
What’s the deal when there are multiple QPs in the chain
Needs to be technical agreement (poss separate QP TA) that documents who is taking resp for what.
If earlier QP is taking some responsibility then they need access to the MA
What additional considerations when certifying imported batches from third country?
Storage conditions of both batch and sample
Travel samples sampling
Provisions if testing is performed on another batch from the same bulk
What are the requirements for travel samples
1) Justification inc QRM that risks are managed inc:
2) Audit of sampling and subsequent shipping conditions to confirm representative
3) Scientific study to show samples are representive when get here
4) Random equivalency analysis
5) Any unexpected or OOS reported to CA of site due to sampling implications
What are the provisions if testing one batch and relying on that testing for other batches from the same bulk?
Need a QRM justification and evidence that integrity and identity of batch established by:
1) Storage conditions of bulk prior to packing were OK
2) Storage and transport conditions of finished batch
3) Stored securely with no tampering
4) ID established
5) Samples tested are representative of all batches made from bulk batch
For re-packed parallel import batches, what does the QP do
1) Prior to certification, QP confirms compliance with nationa requirements for parallel importation
2) Certifies repacking has been performed in line with authorisation and GMP
If relying on 3rd party audit, what’s important about the audit report?
- It needs to be detailed and approved
- It needs t address GMP such as PQS, production and quality procedures
- Concludes whether manufacture of ds or dp is to GMP (or GMP equivalent to UK)
- Compliance to the MA (for outsourced activities)
- An assessment of outsourced critical activities made to QRM
- Audit frequency based on QRM
What’s required for Unexpected Deviation
- It meets the registered specification. OOS = no go
- Deviation investigated – root cause understood. May need a variation
- Impact assessed and no impact to patient or product quality. Therefore no to biologics
- Think about stability
- QP doing final certification is aware
