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PR3145 Compliance and Good Practices in Pharmacy > Role of a Pharmaceutical Inspector > Flashcards

Role of a Pharmaceutical Inspector Flashcards

1
Q

What are the roles of a regulator (inspectors, reviewers, analysts)?

A
  • to weed out adulterated, counterfeits and falsified products
  • to ensure safe, efficacious and quality products
  • to oversee drug/API manufacturing and supply chain
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2
Q

What should pharmaceutical inspectors follow for inspecting manufacturers’ compliance to PICS GMP Standard?

A
  • under SG Medicines Act/ HPA, a Manufacturer’s Licence is required for manufacture of medicinal products (therapeutic products)
  • compliance with PIC/S GMP standard is pre-requisite for issuance and retention of Manufacturer’s Licence
  • GMP compliance assessed through periodic audits by Inspectors from HSA
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3
Q

What is PIC/S’ Goal?

  • means impt
A
  • harmonised GMP standard (for manufacturers)

- quality system (for inspectorates)

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4
Q

What is GMP?

A
  • good manufacturing practice(s)
  • quality system standard to help ensure that:
    ~ medicinal product is CONSISTENTLY manufactured and controlled
    ~ to the QUALITY appropriate for its intended use(s),
    ~ as required by its MARKET AUTHORISATION (product licence)
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5
Q

What is the process of conventional manufacturing flow?

** means impt

A
  1. input
  2. starting materials (APIs, excipients, packaging materials) (WAREHOUSE)
  3. production and packaging
    Processes (weighing, mixing, granulation, drying, compression, coating, packaging/labelling)
    (WEIGHING ROOM, PRODUCTION AREAS, PACKAGING ROOM)
  4. QC testing (QC LAB chem lab, microbiology lab; DOCUMENT AUDIT sop, records, reports, etc.)
  5. Output
    Finished dosage forms
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6
Q

What are the objectives of warehouse inspection?

A
  1. all starting materials (APIs, packaging materials and finished products) have approved specifications, and materials are purchased from approved suppliers
  2. Procedures (SOP) are in place for handling receipt, quarantine, sampling (incl availability of Sampling Room), release of materials and for handling rejected materials and products.
  3. Environment of warehouse (e.g. temp, relative humidity RH monitoring and pest control programmes) preserves quality of materials and products stored
  • CHAP 3 (premises: storage areas)*
  • CHAP 5 (production: starting materials)*
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7
Q

What are the objectives of weighing room inspection? (why is the weighing (dispensing) room inspected?)

** means impt

A
  1. calibrated, accurate and reliable weighing balances are used
  2. weighed materials are of correct identity, qty and qly
  3. authorised personnel wear PPE and env of weighing room controlled to *prevent CROSS-CONTAMINATION *

Item covered during audit of weighing room:

  • calibration of weighing balances
  • labelling of starting materials
  • personnel wear PPE and proper gowns
  • SOP for weighing method (And records of weighing)
  • dust extraction system and housekeeping of weighing room

CHAP 5 (production: dispensing)

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8
Q

What are the objectives of inspecting production department? (why are production areas inspected?)

** means impt

A
  1. premises are designed to prevent cross-contamination
  2. equipment are effectively cleaned and regularly maintained
  3. personnel control programmes in place: restricted access only to authorised personnel; authorised personnel wear PPE
  4. Materials of correct IDENTITY, QTY and QLY are used for production
  5. Process controls are in place (e.g. critical processes are validated/re-validated; in-process qly controls are in place; comprehensive batch processing records are kept)
    * CHAP 5 (production: para 5.1-5.71)*
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9
Q

What are the items/areas covered during inspection of production department?

just need to know what is PMMM

A
  1. Production rooms (PREMISES)
    ~ design/construction
    ~ partition/segregation, air-handling & containment
    ~ connecting pipe-work (stainless steel) and drainage (no back-flow)
    ~ change room (Approp class and air shower)
    ~ cleaning/maintenance and records)
    ~ environmental and microbiological monitoring
  2. Production equipment (MACHINE)
    ~ design and construction
    ~ cleaning/maintenance, calibration and usage records
    ~ status labelling of equipment
  3. Production process (METHOD)
    ~ labelling/control of weighed starting materials
    ~ gowning of production personnel
    ~ batch production records
    ~ process deviation and investigation
    ~ process validation, re-validation and change controls
  4. Personnel (MANPOWER): wear approp PPE and DONT wear cosmetics and jewelry
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10
Q

What are the items/areas covered during inspection of PACKAGING room?

A
  1. Packaging rooms (Premises)
    - design & construction
    - cleaning/ maintenance and calibration
    - environmental and microbiological monitoring
  2. Packaging Equipment (Machine)
    - Cleaning/Maintenance, Calibration and usage records
    - status labelling of equipment
  3. Packaging process (Method)
    - control of labels and packaging Materials, bulk and finished products
    - validation, re-validation and change controls
  4. Personnel (Manpower)
    - gowns and ppe of operator
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11
Q

What are the objectives of inspecting QC department? Why are the QC labs inspected?

** means impt

A
  • properly trained analysts are available & there is Independent Authority for head of QC
  • QC test methods are Approved by HSA & 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 Labelling and Assuring Integrity of QC test equipment, e.g. HPLC, GC, Dissolution tester
  • procedures are in place for Receipt, Storage, Security, Record keeping of test samples, Reagents, and Reference standards
  • CHAP 6 (quality control: para 6.1 to 6.41)*
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12
Q

Which chapter is the PICS Guide GMP on “QC department”?

A

Chap 6

quality control: para 6.1 to 6.41

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13
Q

How many chapters are there in the PIC/S GMP Standard?

A

9

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14
Q

Which chapter is the PICS Guide GMP on “Warehouse”?

A
  • Chap 3 (Premises: Storage Areas)

- Chap 5 (Production: Starting materials)

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15
Q

Which chapter is the PICS Guide GMP on “Weighing Room”?

A
  • Chap 5 (production: dispensing)
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16
Q

Which chapter is the PICS Guide GMP on “Production department”?

A

Chap 5 (Production: Para 5.1-5.71)

17
Q

What are the areas/items covered under inspection of QC labs?

** means impt

A
  • Chem Testing Lab
    ~ Test samples (API, finished products, water, `swabs etc.)
    ~prepared reagents
    ~ reference standards (chemical); pri; sec
    ~ retention samples (for stability or regulatory testing

~ test methods:
: types (e.g. ID, assay, DT)
: Calibration of equipment
: Raw data records and print-outs

~ failure (OOS) investigation
~ stability studies

18
Q

What are the other areas/activities inspected?

A
  1. Ancillary premises (engineering workshop, rest room & wash room. corridors)
  2. External premises/ outsourced activities (contract testing lab; ISO 17025 cert by SPRING sg acceptable by HSA)
19
Q

What are the objectives of documentation audit? Why are documents (SOPs, Records, Reports) audited?

A

1) Legal Requirements under HPA/Med Act complied by manufacturer
2) Regulatory Commitments to HSA are Complied by Manufacturer (e.g. composition of finished product & specifications of starting materials; test methods used; process validation/stability study reports: protocols and acceptance criteria)
3) Manufacturing SOPs, incl Product Quality Reviews, Handling of Complaints, and Recalls and Self-inspection are followed
4) Manufacturing Records are Authentic (no data falsification)
* Manufacturer conforms to Legal and Regulatory Requirements and PIC/S GMP Standard*

20
Q

What are the areas/items covered under documentation audit?

A
  • SOP and Records on Product Quality Review*
  • SOP and records of product complaints and recalls*
  • SOP and records of self-inspection (IQA) program*

Others:

  • document control system (SOP in preparation of SOP, SOP on document control and SOP on record control)
  • SOP & records on pest control
  • SOP and records of temp/RH monitoring
  • Batch manufacturing records
  • Stability testing program
  • process validation program (protocols, acceptance criteria, validation master plan)
  • GMP training program
21
Q

Which chapter does Product Quality Review (PQR) fall under?

A

Chap 1

22
Q

What does PQR consist of?

A
  1. qly of starting materials, finished products and critical in-process controls
  2. failed batches of products
  3. Manufacturing process/QC deviations
  4. changes to manufacturing processes, analysis methods, market authorisations (product licences)
  5. Stability Testing program
    • complaints and product recalls* (investigation and closed out)
    • adequacy of previous CAPAs* carried out
      8, Qualification status of key equipment and utilities (e.g. water, HVAC, steam)
23
Q

What is the main purpose of PQR?

A

PQR results trended, investigated with CAPAs taken based on Root Cause Analysis

24
Q

Which chapter does Complaints and Product recalls fall under?

A

Chap 8

25
Q

What does complaints consist of?

A
  • designated person to handle complaints and decide on action to be taken
  • written procedure SOP on handling complaints
  • all complaints to be recorded, investigated and closed out w decisions taken documented
  • all complaint records should be reviewed regularly for any recurring trend
  • Regulatory (Competent) authority should be notified if manufacturer is considering product recall following serious qly defects, faulty manufacture and evidence of counterfeit products
26
Q

What does Product Recalls consist of?

A
  • designated person independent of Sales and Marketing, should be responsible for coordinating and executing recalls
    • written procedure SOP for product recall
  • distribution records to be readily available to designated person

– Regulatory (Competent) authority where the product is distributed, should be notified if manufacturer is considering product recall

  • recalled product should be stored securely while waiting for decistion on its fate
  • progress of recall process should be recorded and final report issued, incl reconciliation btw delivered and recovered products
  • effectiveness of recall procedure to be evaluated regularly
27
Q

Which chapter does Self-Inspection fall under?

A

Chap 9

28
Q

What does self-inspection consists of?

A
  • carried out at periodic intervals in accordance w pre-arranged program
  • the areas covered during self-inspection should include production, QC, premises, equipment, personnel, documentation, etc. (*ALL 9 CHAP and relevant annexes of PICS GMP standard)
  • self-inspection should be conducted in an independent and detailed way by designated competent persons from company
  • Independent audits by external experts useful too
  • All self-inspections should be recorded, covering observations made during inspections and proposed CAPAs
  • statements of eventual actions taken should also be recorded
29
Q

How many annexes are in PIC/S GMP standard?

A

20

30
Q

Which annexes are not applicable to singapore context/ not necessary to follow?

A

Annex 4 - manufacture of (non-immunological) veterinary products

Annex 5 - manufacture of (immunological) veterinary products

Annex 16 - Qualified person (QP) & Batch Release (applicable to EU only)

Annex 20: Quality Risk Management (Voluntary)

BUT ALL 9 chapters are mandatory

PR3145 Compliance and Good Practices in Pharmacy (6 decks)

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