BioProductions-L04

Question 1

cGMP stands for?

Answer 1

Current Good Manufacturing Practices

Question 2

Aim of cGMP?

Answer 2

Ensure the, product is safe, pure and effective for the patients

Question 3

Who benefits from us complying with the cGMPs/GDP?

Answer 3

Patients

Question 4

What is cGMP apart of?

Answer 4

Quality Assurance

Question 5

Agencies we must be Compliant/Aligned with

Answer 5

Singapore - Health Sciences Authority (HSA)
USA - United States Food and Drug Administration (USFDA)
European Union - European Medicines Agency (EMA)

Question 6

cGMP regulations are…?

Answer 6

Ensuring that drug products are consistently produced to meet quality standards. These practices are required to maintain the safety, identity, strength, quality, and purity of food, drugs, and active pharmaceutical products, protecting consumer health. (E.g. SOP, QC)

Question 7

What is the “c” in cGMP?

Answer 7

Current
-Technologies & systems that are up-to-date

Question 8

GMP vs cGMP

Answer 8

GMP is recognized worldwide for the control and management of manufacturing and quality control testing of foods, pharmaceutical products and medical devices.

cGMP is an updated guideline which requires companies to use technologies and systems that are up-to-date in order to comply with the regulations.

Question 9

What defines an effective medicine?

Answer 9

21 CFR 210.1(a)
– Safety,
– Identity
– Strength
–Purity
–Quality

Question 10

GMP Manufacturing plants

Answer 10

cGMP
Compliance + Following
Written
Procedure = Quality
Product

Question 11

Applicable GMP Regulations and Guidance

Answer 11

Laws in place

Question 12

What is under “Code of Federal Regulations (CFR) Title 21”?
(PROB GENERAL KNOWLEDGE)

Answer 12

– Part 11 – Electronic Records and Signatures
– Parts 210 and 211 – Finished Pharmaceutical GMPs
– Part 600 – Biologic Product cGMPs
– Part 820 – Quality System Regulation (Medical Device cGMPs)

Note – Only 21 CFR Parts 210/211 and applicable sections of 600 content are
covered in this course

Question 13

What is under “International Conference for Harmonization (ICH)”?

Answer 13

– Q7 – GMPs for APIs (Binding in the European Union)
– Q10 – Pharmaceutical Quality System (Guidance for All)

Question 14

Part 210

Answer 14

• 210.1 (a) Minimum GMP Practices
  –Manufactures
  –Processing
  –Packing
  –Holding

Question 15

Part 211

Answer 15

• Outlines the minimum GMP requirements for finished drug products.
• Also covers various other areas, including personnel, facilities and equipment, production processes, stability testing, and labeling.

Question 16

What is Document Hierarchy and Quality Management System (QMS)?

Answer 16

• Quality is incorporated into a biopharma companies through a Quality Management System (QMS), which consists of a hierarchy of quality documents
  to support the quality policy of the company

Question 17

Hierarchy

Answer 17

1. Quality policy
2. Quality manual
   (Aft Process maps, flow charts & visual aids)
3. SOP Standard Operating Procedures
4. Work instructions, guidance
5. Other Document types

Question 18

Quality Policy

Answer 18

A quality policy should make a
statement about the company’s commitment to
quality and continual improvement of its processes.

Question 19

Quality Manual

Answer 19

Contain these basic
elements:
-document title
-table of contents
-scope and exclusions
-information on version and approval
-description of the Quality Management
System
-the company’s business process model
-definitions of employee
responsibilities
-references to relevant
documents and appendices

Question 20

SOP

Answer 20

ICH defines SOPs as “detailed, written instructions to achieve uniformity” of the performance od a specific function

Question 21

SOP contains…

Answer 21

SOP procedures should contain the document title,
its purpose and scope, responsibilities and
authorities, descriptions of all activities, and references to any relevant SOPs, work instructions, and records.

Question 22

Work instructions

Answer 22

Same elements as the SOP procedures, and are similar in structure.

Question 23

SOP vs Work instructions

Answer 23

Work instructions are more detailed, covering activities that must be done, the steps to take and in what order, what tools and methods should be used, and accuracy requirements.

Question 24

Records and forms

Answer 24

Provide proof that your activities and processes
are done in the manner that is specified in the procedures and the work instructions.
E.g Training forms, Batch record, cleaning logbooks

Question 25

GDP stands for?

Answer 25

Good Documentation Practices

Question 26

Why is GDP Important?

Answer 26

-Ensure product: Safety, Identity, Strength, Purity, Quality -Per 21 CFR Parts 210.1 : “Failure to comply with any regulation set forth ...shall render such drug to be adulterated …” -GDP provides proof that procedures have been followed and that actions or events took place. -cGMP regulations are required by law and enforced by International and domestic Regulations -“If it’s not documented, it didn’t happen” -Complete and accurate records demonstrate our quality systems.

Question 27

6 principles of Good Documentation

Answer 27

-Permanent -Clear -Timely -Correct -Traceable -Complete

Question 28

Good Documentation is a must to...

Answer 28

Quality Records must stand alone and provide a clear and accurate history of an activity or event.

Question 29

Permanent

Question 30

Clear

Question 31

Timely

Question 32

Correct

Question 33

Traceable

Question 34

Complete

Question 35

GLP stands for?

Answer 35

Good Laboratory Practices

Question 36

Good Laboratory Practice (GLP) is a standard by which laboratory studies are:

Answer 36

Designed, performed, monitored, recorded, reported archived

Question 37

GLP procedures follows..?

Answer 37

According to SOPs to assure the public that the test results are correct and the experiment can be reproduced exactly, at any time in the future.

Question 38

Main focus of GLP

Answer 38

The main focus of GLP is to help assure regulatory authorities that the data submitted are true and are reliable enough to establish risk/safety limits and determine product specifications.

Question 39

What are Good Laboratory Practices?

Answer 39

To ensure that the data generated from the testing labs are true, accurate and reliable, (data integrity), the testing lab will conduct non-clinical studies according to the principles of Good Laboratory Practices (GLP). * People, process, equipment, environment: * Any factor that can affect the quality and integrity of the data has to be checked, calibrated and validated. * This is to increase confidence in the customer or the regulatory authorities that the data has integrity and is of quality

Question 40

Example of GLP

Answer 40

* A product specification must meet a specification of pH 7.4 to be certified and allowed to release to the customer. We check the product pH using a pH meter. If it gives a reading of pH 7.4, we would pass the product. **To ensure that the pH meter is reading accurately, we must also check it. We will check if the pH meter is calibrated properly, and that it can be used for testing pH in the product (this is validation)

Question 41

Calibration (Slide 72)

Answer 41

* Calibration is a documented comparison of the measurement device to be calibrated against a traceable reference standard/device. The reference standard may be also referred to as a “calibrator.” Logically, the reference standard should be more accurate than the device to be calibrated. * Calibration with a known standard or reference, allows an unknown test sample to be measured accurately and precisely, ensuring confidence in the data.

Question 42

Validation (Slide 73)

Answer 42

* Validation is the testing of the equipment or the method with a reference to determine if the equipment or method is able to measure the unknown sample. * For example, can the ELISA test kit work to detect Covid-19 virus at low concentrations? We perform tests with dilutions of Covid-19 virus until the diagnostic kit cannot measure a reading anymore. We have validated the lower limits of the assay.