Lecture 1 Role of Pharmaceutical Inspector Flashcards
(33 cards)
1
Q
what are counterfeits usually made by
A
backyard manufacturers
2
Q
medicinal products with false representation have falsified:
A
- name of the manufacturer
- name of market authorisation holder
- batch number
- packaging/ labeling
- identity/ composition
- manufacturing records/ cert of analysis
3
Q
role of regulator in accessing medicinal products
A
- weed out adulterated, counterfeits, and falsified products
- ensure safe, efficacious, and quality products
- oversee drug/ API manufacturing and supply chain
4
Q
role of pharmaceutical inspector
A
inspecting manufacturers compliance to PICS GMP standard
- under Med Act/ HPA, manufacturer license is required
- compliance with PIC/S GMP standard is pre-req for issuance and retention of Manu. license
- GMP compliance assessed through periodic audits by inspectors from HSA
5
Q
conventional manufacturing flow
A
- input
- production and packaging
- QC testing
- output
6
Q
input of manufacturing
A
contains starting materials such as: APIs, excipients, packaging material
7
Q
processes involved in production and packaging of manufacturing
A
DCC GP/L WM
- Drying
- Coating
- Compression
- Granulation
- Packaging/labeling
- Weighing
- Mixing
8
Q
where does QC testing usually take place at, and what do they do
A
where: QC labs (chem/microbio lab)
what: SOP, records, reports, etc
9
Q
outputs of manufacturing
A
finished dosage forms: tablets, capsules, cream, ointment, liquids, eyedrops, injections
10
Q
the objective of warehouse inspection
A
- assess all starting materials have approved specifications, and materials are purchased from approved suppliers
- assess procedures (SOP) are in place for handling receipts, quarantine, sampling (availability of sampling room), release of materials & for handling rejected materials and products
- assess environment of warehouse preserves quality of materials and products stored
11
Q
objectives of weighing room inspection
A
assess that:
- calibrated, accurate and reliable weighing balances are used
- weighed materials are of correct identity, quality and quantity
- authoritised personenel wear appropriate PPE and environment of weighin room controlled to prevent cross contamination
12
Q
what are items covered during audit of weighing room
A
- calibration of weighing balances
- labeling of starting materials
- personnel wear proper gowns and PPE
- SOP for weighing methods (& records of weighing)
- dust extraction system and housekeeping of weighing room
13
Q
objective of inspecting production departments
A
assess:
- premises are designed to prevent cross-contamination
- equipment are effectively cleaned and regularly maintained
- personnel control programs are in place
- materials of correct identity, quantity and quality are used for production
- process controls are in place
14
Q
types of personnel control programmes
A
- restricted access only to authorised personnel
2. authorised personnel wear appropriate gowns and PPE
15
Q
types of process controls
A
- critical processes are validated/ re-validated
- in-process quality controls are in place
- comprehensive batch processing records are kept
16
Q
items/ areas to be covered during inspection of production department (room)
A
- (premises):
- design/construction
- partition/segregation, air handling and containment
- connecting pipework (stainless steel), drainage (no backflow)
- change room (appropriate class and air shower)
- cleaning/ maintenance and record
- environmental and microbiological monitoring
17
Q
items/ areas to be covered during inspection of production department (equipment)
A
- (machine)
- design and construction
- cleaning/maintenance, calibration, and usage records
- status labeling of equipment
18
Q
items/ areas to be covered during inspection of production department (process)
A
- (method)
- labeling control of weighted starting materials
- gowning of production personnel
- batch production records
- process deviation and investigation
- process validation, revalidation and change controls
19
Q
items/ areas to be covered during inspection of production department (personnel)
A
- (manpower)
- wear appropriate PPE and do not wear cosmetics and jewelry
20
Q
items/ areas to be covered during inspection of the packaging room
A
- premises:
- design and construction
- cleaning/maintenance and calibration
- environmental and microbiological monitoring
21
Q
items/ areas to be covered during inspection of the packaging equipment
A
- machine
- cleaning/ maintenance, calibration and usage records
- status labeling of equipment
22
Q
items/ areas to be covered during inspection of the packaging process
A
- method:
- control of labels and packaging materials, bulk and finished products
- batch packaging records
- validation, revalidation and change controls
23
Q
items/ areas to be covered during inspection of the packaging personnel
A
- manpower:
- gowns and PPE
24
Q
objectives of inspecting QC departments
A
assess that:
- properly trained analysts are available and there is independent authority for head of QC
- QC test methods are approved by HSA and are robust, sensitive, accurate and reliable for testing as evident from records of analytical method validation and routine QC test results
- procedures are in place for maintenance, calibration, status labeling and assuring integrity of QC test equipment (eg. HPLC, GC, dissolution tester
- procedures are in place for receipt, storage, security, record-keeping of test samples, reagents and reference standards
25
areas/ items covered under inspection of QC labs
aka chem testing lab:
- test samples
- prep reagents
- ref standards (chemical: primary; secondary)
- retention samples (for stability or regulatory testing)
- test methods (types, calibration of equipment, validation, raw data records and print outs)
- failure (OOS) investigation
- stability studies
26
other areas/ activities inspected
1. ancillary premises:
- engineering workshop
- rest room and wash room
- corridors
2. external premises / outsource activities
- contract testing labs
27
objective of documentation audits
assess that:
1. legal requirements under med and HP act are complied by manufacturer
2. regulatory commitments to HSA are complied by manufacturers
3. manufacturing SOPs, including those on product quality reviews, handling of complaints and recalls and self inspection, are followed
4. manufacturing records are authentic, no falsification of data
28
types of regulatory commits to HSA does manufacturers need to comply to
1. composition of finished products and specifications of starting materials
2. test methods used
3. process validation/ stability study reports: protocols of starting materials
29
areas/items to cover under documentation audit
1. document control system (SOP on Preparation of SOP, Document Control and Record Control)
2. SOP and records on pest control
3. SOP and records of tempatature/ RH monitoring
4. batch manufacturing records
5. stability testing program
6. process validation program
7. GMP training program
8. SOP & records on Product Quality Review/ Product Compliants and Recalls, Self Inspection IQA Program
30
what should PQR be conducted annually on authorised products about?
1. quality of starting materials
2. quality of finished products and critical in-process controls
3. failed batches of products
4. manufacturing process/QC deviations
5. changes to manufacturing processes and analysis methods
6. changes to market authorisations (product lisences)
7. stability testing program
8. complaints and product recalls- investigations and closed out
9. adequacy of previous CAPAs carried out
10. qualification status of key equipment and utilities (eg. water, HVAC, steam)
31
complaints procedures
- designated person should be responsible for handling complaints and deciding on actions to be taken
- written SOP on handling complaints should be in place
- all complaints shall be recorded, investigated and closed out with decisions taken documented
- all complaint records should be reviewed regularly for any recurring trend
- the competent authority should be notified if manufacturer is considering product recall following serious quality defects, faculty manufacture and evidence of counterfeit products
32
product recalls
- designated person, independent of sales and marketing, should be responsible for coordinating and executing recalls
- written procedure should be in place for product recall
- distribution records should be readily available to the designated person
- competent authorities where the product is distributed, should be notified if manufacturer is considering product recall
- recalled product should be stored securely while awaiting decision on its fate
- progress of recall process should be recorded and final report issued, including a reconciliation between delivered and recovered products
- effectiveness of recall procedure should be evaluated regularly
33
self inspection
- carried out at periodic intervals in accordance with pre-arranged program
- areas covered during self-inspection should include production, QC, premises, equipment, personnel, documentation
- self-inspection should be conducted in an independent and detailed way by designated competent persons from company
- independent audits by external experts are also useful
- all self-inspections should be recorded, covering observations made during inspections and proposed CAPAs
- statements of eventual actions taken should also be recorded
