Following are the key things you should look for pre approval inspection.
- Deviations, OOS, product failures
- Investigations and CAPA’s
- Label control
- QA oversight
- Management oversight
- Drug Safety and Pharmacovigilance projects
- Process, shipping cleaning method
- Vendor and contractor qualification and oversight
Deviations gives the indication of break down in one or all of the following:Equipment, processes, SOP’s, training, culture, QA or management oversight
Product failures are indicators of one or more of the following:Equipment, processes, SOP’s, training, culture, QA or management oversight as well as testing, specifications and change control
Investigations contain following things
- Depth of root cause analysis
- asking all the questions
- is the documentation Adequate
- A recurring theme and if so why“Super investigation” initiation
- Adequate time allocated Investigation completed in a timely manner
- Management awareness of issues
CAPA
- Point issue versus holistic solution
- Logical and encompassing CAPA’s
- CAPA effectiveness – evidence
- Adequate time allocated
- Recurring issues – is the CAPA a cut and paste
- SOP rewrite and training do not solve all problems
- Management awareness of issues – did they act in a timely fashion
Label Control
- Largest reason for recall
- Processes for master labeling control must be adequate
- Label control on production floor must be defined and followed
- Labelers and packaging lines must be validated
- Process history must support operations
QA Oversight/Mgt Oversight
- Very clear in Warning Letters but sometimes hidden in 483’s
- QA disposition lots not a committee
- QA’s role in stopping production
- QA reporting relationship –org charts must represent real life
- Discretionary budget
- QA’s voice at the right table
- Does the senior person on site know what is going on
- This could be the CEO
- Does the head person hear the good and the bad news and from whom
Validation (Proc, Ship, Clean & QC )
- Is it a living discipline? Or is it a paper hurdle?
- Is validation a one time activity?
- Development reports must support validation which supports batch records
- Validation is not a development activity
- Validation must support what you claim for your process
- Methods used, in compendial, must be valid
- Deviations in the reports must be addressed