Lesson 1. Introduction to cGMPs and PIC/S

Current Good Manufacturing Practices

comprehensive quality assurance system designed to ensure that medicinal products are consistently produced, controlled, and verified according to established quality standards.

Food and Drug Administration

cGMP are guidelines required by the Philippine regulatory board known as _____________________.

Good Documentation Practices, Good Laboratory Practices, Good Distribution Practices, and Good Storage Practices

Apart from cGMPs, the industry are also guided by ______________________________________.

meticulously built in every single stage

Quality cannot be merely testes into a product; it must be _________________________ of the manufacturing process.

contamination can occur

Finished Product Quality Testing (FPQC) is not enough to ensure that quality is being built in the product itself as ___________________ anywhere within the manufacturing processes and for sustainability to minimize rejections and financial loss.

sampling

In FPQC, we only use _______________ and not test the whole batch as most tests are destructive to the final drug product.

Personnel

THE OPERATIONAL MATRIX OF cGMP:

• ensures all operators and supervisors are properly trained, qualified, and follow strict gowning and personal hygiene protocols to prevent contamination

Production Manager

THE OPERATIONAL MATRIX OF cGMP:

• There should be a different a.___________________ which is responsible for following the quota and a different b._______________________ which assures, checks, and monitors what is being done by the production to keep c.________________________________.

a = ?

Quality Control Manager

THE OPERATIONAL MATRIX OF cGMP:

• There should be a different a.___________________ which is responsible for following the quota and a different b._______________________ which assures, checks, and monitors what is being done by the production to keep c.________________________________.

b = ?

independence and be unbiased

THE OPERATIONAL MATRIX OF cGMP:

• There should be a different a.___________________ which is responsible for following the quota and a different b._______________________ which assures, checks, and monitors what is being done by the production to keep c.________________________________.

c = ?

processes that involves the pharmaceutical product

THE OPERATIONAL MATRIX OF cGMP:

• If a person is sick, they should not be in contact with _________________________________________.

Premises and Equipment

THE OPERATIONAL MATRIX OF cGMP:

• Designing facilities with controlled air systems (HVAC) to prevent cross-contamination, and ensuring that all production machinery is regularly cleaned, maintained, and calibrated.

separate gowning, weighing, compounding, filling, and packaging area

THE OPERATIONAL MATRIX OF cGMP:

Premises and Equipment

• In the laboratory, there is a _____________________________________ to stimulate the real industry.

material

THE OPERATIONAL MATRIX OF cGMP:

Premises and Equipment

• It also tells which ___________ should the equipment be made out of.

calibrated

THE OPERATIONAL MATRIX OF cGMP:

Premises and Equipment

• All equipment must be ___________ such as the RPM of mixers.

penicillin and cephalosporin

THE OPERATIONAL MATRIX OF cGMP:

Premises and Equipment

• Products with a biological active pharmaceutical ingredient such as _____________________ should be compounded in a separate building, equipment, and personnel because these products can leech in the walls risking contamination.

Documentation

THE OPERATIONAL MATRIX OF cGMP:

• Mandating precise, real-time record-keeping to provide complete traceability, allowing any batch to be fully reconstructed from raw materials to distribution

journey of the drug product

THE OPERATIONAL MATRIX OF cGMP:

Documentation

• All things should be documented as you do it because it keeps track of the whole ________________________________________.

troubleshooting

THE OPERATIONAL MATRIX OF cGMP:

Importance of Documentation

1. For _____________________ to know what went wrong in the manufacturing process during final checks (ex: FPQC)

2. For drug _______________________

1 = ?

recalls and complaints

THE OPERATIONAL MATRIX OF cGMP:

Importance of Documentation

1. For _____________________ to know what went wrong in the manufacturing process during final checks (ex: FPQC)

2. For drug _______________________

2 = ?

Self-Inspection

THE OPERATIONAL MATRIX OF cGMP:

• conducting routine internal audits to proactively evaluate compliance, identify operational deficiencies, and implement Corrective and Preventive Actions (CAPAs) before products leave the facility.

Pharmaceutical Inspection Co-operation Scheme (PIC/S)

non-binding, informal cooperative arrangement between regulatory authorities globally in the field of GMP

international development, implementation, and maintenance

PIC/S aims to lead the ______________________________________ of harmonized GMP standards and quality systems for inspectorates.

unified framework

PIC/S provides a ____________________.

standardized guidance documents

PIC/S develops __________________________ such as PIC/S GMP Guide

reduces inspection redundancy

PIC/S make it easier to export drug products to another country because it a.________________________. Even though it is non-binding, if your company and the company you wish to export to follow PIC/S, it makes exportation easier because it b.___________________________.

a = ?

standardizes guidelines

PIC/S make it easier to export drug products to another country because it a.________________________. Even though it is non-binding, if your company and the company you wish to export to follow PIC/S, it makes exportation easier because it b.___________________________.

b = ?

daily operational boundaries

GMP and PIC/S serves as _____________________________.

exchange of inspection data

RELEVANCE OF PIC/S TO THE PHARMACIST AND THE PHARMACEUTICAL QUALITY SYSTEM:

1. facilitates the _______________________________________

2. reduces the need for ________________________________

3. ensures that the global drug supply chain remains ______________________________________-

1 = ?

redundant, overlapping international plant inspections

RELEVANCE OF PIC/S TO THE PHARMACIST AND THE PHARMACEUTICAL QUALITY SYSTEM:

1. facilitates the _______________________________________

2. reduces the need for ________________________________

3. ensures that the global drug supply chain remains ______________________________________-

2 = ?

secure, uniform, and focused on patient safety

RELEVANCE OF PIC/S TO THE PHARMACIST AND THE PHARMACEUTICAL QUALITY SYSTEM:

1. facilitates the _______________________________________

2. reduces the need for ________________________________

3. ensures that the global drug supply chain remains ______________________________________-

3 = ?