Introduction -[Current Good Manufacturing Practices (CGMP)]

US Food and Drug Administration (FDA)

Current Good Manufacturing Practices (CGMP) was first promulgated by the______ in 1963.

1963

Current Good Manufacturing Practices (CGMP) was first promulgated by the US Food and Drug Administration (FDA) in _____ ?

Current Good Manufacturing Practices (CGMP)

Were established to ensure that minimum standards are met for drug product quality

Quality

It refers to the perception of the degree to which the product or service meets the customer's expectations.

Good Manufacturing Practice (WHO 2007)

Part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use.

1. Food

2. Cosmetics

3. Medical Devices

4. Household and Urban Substances

FDA Regulated Products [4]

Good Manufacturing Practice (AO 43 s. 1999)

System of quality assurance aimed at ensuring that products are consistently manufactured to a quality appropriate for intended use

Good Manufacturing Practice (AO 43 s. 1999)

Concerned with manufacturing and quality control processes and procedures.

Good Manufacturing Practice

Part of quality assurance which ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use.

Quality Assurance

The sum total of the organized arrangements made with the object of ensuring that medicinal products are of the quality required for their intended use.

Quality Assurance

It is a wide-ranging concept which covers all matters which individually or collectively influence the quality of a product.

Man (personnel)

Method (procedures)

Materials

Machine (equipment)

4Ms (Factors Influencing Quality)

AO 43 s. 1999

[PHILIPPINES GMP REGULATION]

• Adoption of the 1st edition of the Current Good Manufacturing Practice Guidelines by the Bureau of Food and Drugs (former FDA).

AO 2012-0008

[PHILIPPINES GMP REGULATION]

• Adoption and implementation of the PIC/S GMP as the standard for the manufacture of pharmaceutical products.

FDA Memorandum Circular 2012-004

[PHILIPPINES GMP REGULATION]

• The Philippine FDA mandated all drug manufacturers to ensure strict and full compliance to the newly adopted PIC/S GMP.

• Pharmaceutical Inspection Convention (PIC)

• Pharmaceutical Inspection Co-operation Scheme (PICS)

[PHILIPPINES GMP REGULATION]

_____- European member countries.

_____- Non-European member countries.

I

[Identify the Chapters of PIC/s GMP]

Quality management

II

[Identify the Chapters of PIC/s GMP]

Personnel

III

[Identify the Chapters of PIC/s GMP]

Premises and equipment

IV

[Identify the Chapters of PIC/s GMP]

Documentation

V

[Identify the Chapters of PIC/s GMP]

Production

VI

[Identify the Chapters of PIC/s GMP]

Quality control

VII

[Identify the Chapters of PIC/s GMP]

Contract manufacture and analysis

VIII

[Identify the Chapters of PIC/s GMP]

Complaints and product recall

IX

[Identify the Chapters of PIC/s GMP]

Self inspection

1. Repeatable

2. Compliance

3. Validated

4. 4M + P (Man, Method, Materials, Machine + Premises and spaces)

5. Documentation, DIR (Data Integrity Record)

6. History

7. Complaints and product recall

Requirements Summary of PIC/s GMP

1. All manufacturing processes are clearly defined, systematically reviewed, and shown to be capable of consistently manufacturing medicinal products of the required quality and complying with their specification.

2. Critical steps of the manufacturing process and significant changes to the process are validated.

3. All necessary facilities for GMP are provided, including:

   • appropriately qualified and trained personnel

   • adequate premises and space

   • suitable equipment and services

   • correct materials, containers and labels

   • approved procedures and instructions

   • suitable storage and transport

4. Instructions and procedures are written in an instructional form in an unambiguous language specifically applicable to the facilities provided.

5. Operators are trained to carry out procedures correctly; procedures should not be memorized but read from documents like the Master Formula.

6. Records are made during manufacture which demonstrate that all required steps were taken and that the quantity and quality of the product was as expected. Any significant deviations are fully recorded and investigated.

7. Records of manufacture and distribution, which enable the complete history of a batch to be traced, are retained in a comprehensible and accessible form.

8. The distribution of the products minimizes any risk to their quality.

9. A system is available to recall any batch of product from sale or supply.

10. Complaints about marketed products are examined. The cause of quality defects is investigated, and appropriate measures are taken to address defects and prevent reoccurrence.

Basic Requirements of GMP (PIC/s 2009)

True

Basic Requirements of GMP (PIC/s 2009)

[T/F]

All manufacturing processes are clearly defined, systematically reviewed, and shown to be capable of consistently manufacturing medicinal products of the required quality and complying with their specification.

True

Basic Requirements of GMP (PIC/s 2009)

[T/F]

Critical steps of the manufacturing process and significant changes to the process are validated.

True

Basic Requirements of GMP (PIC/s 2009)

[T/F]

All necessary facilities for GMP are provided, including:

• appropriately qualified and trained personnel

• adequate premises and space

• suitable equipment and services

• correct materials, containers and labels

• approved procedures and instructions

• suitable storage and transport

Instructional form

Basic Requirements of GMP (PIC/s 2009)

Instructions and procedures are written in an ____in an unambiguous language specifically applicable to the facilities provided.

memorized

Basic Requirements of GMP (PIC/s 2009)

Operators are trained to carry out procedures correctly; procedures should not be _____but read from documents like the Master Formula.

Records

Basic Requirements of GMP (PIC/s 2009)

____ are made during manufacture which demonstrate that all required steps were taken and that the quantity and quality of the product was as expected. Any significant deviations are fully recorded and investigated.

fully recorded and investigated

Basic Requirements of GMP (PIC/s 2009)

Records are made during manufacture which demonstrate that all required steps were taken and that the quantity and quality of the product was as expected. Any significant deviations are _____ and____

comprehensible and accessible form

Basic Requirements of GMP (PIC/s 2009)

Records of manufacture and distribution, which enable the complete history of a batch to be traced, are retained in a ______and _____ form.

True

Basic Requirements of GMP (PIC/s 2009)

[T/F]

The distribution of the products minimizes any risk to their quality.

recall

Basic Requirements of GMP (PIC/s 2009)

A system is available to _____ any batch of product from sale or supply.

Complaints

Basic Requirements of GMP (PIC/s 2009)

______- about marketed products are examined. The cause of quality defects is investigated, and appropriate measures are taken to address defects and prevent reoccurrence.

quality defects

Basic Requirements of GMP (PIC/s 2009)

The cause of _____is investigated, and appropriate measures are taken to address defects and prevent reoccurrence.

1. Ensures Product Quality and Safety

   • Guarantees that medicines are safe, effective, and of good quality.

   • Prevents substandard, con

2. Promotes Consistency in Manufacturing

   • Ensures uniformity in every batch produced.

   • Reduces batch-to-batch variation through standardized procedure

3. Prevents Contamination and Mix-Ups

   • Requires proper facility design, sanitation, personnel hygiene, and equipment maintenance.

   • Minimizes cross-contamination and labeling errors.

4. Ensures Proper Documentation and Traceability

   • Requires complete and accurate records (SOPs, batch records).

   • Allows tracing of errors, deviations, or product recalls when needed.

5. Strengthens Quality Assurance and Quality Control Systems

   • Establishes clear roles for QA and QC in testing, approval, and release of products.

   • Ensures compliance with pharmacopeial and regulatory standards.

6. Protects Public Health

   • Ensures patients receive medicines that meet safety and efficacy requirements.

   • Reduces risks of therapeutic failure or adverse drug reactions.

7. Supports Regulatory ComplianceProtects Public Health

   • Compliance with cGMP is mandatory for licensing and product registration.

   • Prevents regulatory sanctions, recalls, and plant shutdowns

8. Enhances Professional Accountability

   • Ensures pharmacists and manufacturers uphold ethical and professional responsibilities

   • Promotes accountability at every stage of production.

Importance of the Provisions of cGMP