Pharmaceutical Inspection: Topics of Special Interest Flashcards
What is a remote inspection vs an on-site inspection?
- On-site inspection
- Inspectors are physically present at manufacturing site to assess company’s compliance with GMP (or GXP) standards and other regulatory requirements. - Remote inspection (aka off-site, virtual, distant or e-inspection)
- Mimics on-site inspection, enabled by e-technology.
- Strives to mimic on-site inspection in terms of format, time-frame and overall rigot - Desktop inspection:
- A form of remote inspection based on review of documentary evidence provided by the company; largely a “paper-based” remote inspection.
Hybrid inspection is a combination of all three.
What are the arrangements for remote inspections?
- Agree on Virtual Conference (Inspection) Platform
- Assure Strong Internet/ Wifi Connectivity Audio Visual Resolution of Webcam System
- Know the Parties Involved & Their Roles
- Agree on Inspection Time and Duration , and Time Zones for Remote Overseas Inspections
- Make Arrangements relating to Confidentiality, Security & Access to File Sharing Platforms
- Agree on Safety Arrangements
- Deal with Document System (Likely to be Hybrid), comprising Paper and Electronic Records
What are the challenges of remote inspections?
- Existing e Technology Limitations due to Unstable Internet Connectivity Poor AV Resolution
- Limited Resources at Manufacturing Sites (due to Split Teams ) during COVID- 19 Pandemic
- Overall Slower Response Time to complete a remote inspection
- Lack of body language can distort discussions
- Difficult to inspect utilities and manufacturing operations
- As technology advances & use of digital tools become norm, Remote Inspections
may not be so challenging. - As of now, Remote Inspections tend to be largely Desktop Inspections; however, post Covid-19 may see more Hybrid Inspection and Use of Mutual Reliance Program.
What are the benefits of PIC/S membership?
- Reduced Duplication of GMP Inspections
- Increased Opportunity for Collaborations
What is the core framework used for the ASEAN Sectoral MRA, on GMP Inspection, and what does the MRA cover?
Framework: PIC/S
Covers:
- Pharmaceutical products in finished dosage forms
- Both prescription medicines and OTC products
- Does not cover biopharmaceutical products and APIs
What are the benefits of ASEAN MRA on GMP Inspection?
- Avoids duplication of Pharmaceutical Inspections within ASEAN
- Saves Time , Resources and Costs for Manufacturers & Regulators
- Facilitates Trade in Medicinal Products across ASEAN
- Quicker Access of Medicinal Products by ASEAN Patients
- Also Harmonizes ASEAN Inspection System to that of PIC/S
- Increases Attractiveness of ASEAN to Regulators & Investors from Asia & Rest of the World!
Negotiations of MRA
- MRA can take a relatively long time to negotiate/conclude.
- Often, MRAs are negotiated under larger platform of Free Trade Agreements (FTAs).
- MRA negotiations involve Regulators , Lawyers/AGC, Trade & Industry Representatives etc.
- Considerations are given to Pharmaceutical Import/Export
Volumes, Political, Legal, Social & other Trade/Services - Mutual reliance approach (MRA) could be a good first step forward
What does the framework of PIC/S GMP Inspection include?
- Having a MRA on GMP Inspection in place; or
-Recognition of GMP Compliance Status of a facility located within territory of a
PIC/S Participating Authority ; or
-Recognition of inspection outcome by a Hosting Inspectorate
which has been assessed under a robust framework, e.g.
PIC/S JAP or JRP
WHO Good Reliance Practices
- Covers Reliance Activities in Regulation of Medical Products
- Spans the entire product life cycle and includes GMP inspections
- Intended for all national regulatory authorities regardless of their maturity levels and resources.
- WHO recommends various approaches to reliance.
What is reliance (according to the WHO Good Reliance Practices)
- An act whereby an NRA takes into account an assessment performed
by another NRA (or trusted institution) in reaching its own decision. - The relying NRA remains independent, responsible & accountable for
decisions taken, even as it relies on the assessment of another NRA. - Reliance does not represent a less stringent form of regulation or an
outsourcing of regulatory mandate - On the contrary, mutual reliance is the hallmark of a modern and
efficient regulatory authority and smart regulation
The use of ______ and ____ can be a viable alternative to on-site inspections.
remote inspections, reliance
Benefits of remote inspections and reliance
- Remote Inspections Have Enabled Business Continuity During Covid 19; and
- Post COVID 19, They Can Decrease Travel Times for Domestic & Overseas Inspections
- Accord Flexibilities to Inspectors & Inspectees regarding Time Frames & Inspection Pace
-During current pandemic, remote inspections reliance are the only 2 options
available for Overseas Manufacturers
What are the different GMP assessment approaches that most national laws allow for?
on-site, remote or hybrid inspections, or use of reliance
What are the advantages of nanomedicines?
- Effective in Targeting Difficult To Reach ( Tumour ) Sites
- Improved Solubility, Bioavailability & Reduced Side Effects
- Achievement of Same Therapeutic Effect with Smaller Doses
Why do nanomedicines have special properties?
due to their unique size, shape and surface chemistry
