Pharmacists’ Role in Cosmetic Industry Practices

• Offer assistance to the cosmetic industry in compliance with the provisions of the ASEAN Cosmetic Directive

• Only a general guideline for the manufacturers to develop its own internal quality management system and procedures.

ASEAN GUIDELINES FOR COSMETICS GOOD MANUFACTURING PRACTICES

ASEAN GUIDELINES FOR COSMETICS GOOD MANUFACTURING PRACTICES

Objective?

The final products must meet the quality standards appropriate to their intended use to assure consumer's health and benefit

ASEAN COSMETIC GMP MODULES (Consist of the following) [13]

• Quality Management System

• Personnel

• Premises

• Equipment

• Sanitation & Hygiene

• Production

• Internal Audit

• Quality Control

• Documentation

• Storage

• Product Complaint

• Product Recall

• Contract Manufacturing Analysis

ASEAN COSMETIC GMP MODULES

• Understand the key concepts of quality management, quality assurance, QMP quality control, the level of quality, documentation and the specific requirements on quality manuals.

Quality Management System

ASEAN COSMETIC GMP MODULES

• Provide an in-depth understanding regarding general requirement of the personnel in the cosmetic manufacturing facilities and be able to disseminate the information on the organisation structure.

Personnel

ASEAN COSMETIC GMP MODULES

• Defining the area used for manufacturing process best is suitably located, designed, constructed…

Premises

ASEAN COSMETIC GMP MODULES

• Ensure the equipment and apparatus used for manufacturing process that must be made with stable and proper material, correct design, safe and easy to operate.

Equipment

ASEAN COSMETIC GMP MODULES

• Its aim is to eliminate all potential sources of contamination and cross-contamination from all areas where the product quality is at risk

Sanitation & Hygiene

ASEAN COSMETIC GMP MODULES

• Manufacture good & safe products, deliver products with good efficacy, standardize all actions related to production activities, and ensure the consistency of product quality by using only approved starting materials

Production

ASEAN COSMETIC GMP MODULES

• Define the activities and requirements of IA, identify the roles and benefits of IA in a quality management system and learn how to plan, perform and monitor IA.

Internal Audit

ASEAN COSMETIC GMP MODULES

• Understand key elements in quality control and specific requirements on organization, procedures, processes and resources.

Quality Control

ASEAN COSMETIC GMP MODULES

• Review general requirements for documents, specific requirements for each document and give general guidance how to create good documentation system

Documentation

ASEAN COSMETIC GMP MODULES

• Gain basic understanding of the Good Storage Practice (GSP) applicable to the warehouse, list the key GSP requirements for storage of the materials or cosmetic products.

Storage

ASEAN COSMETIC GMP MODULES

• Identify the key issues in product complaints and put in place a system, procedures and resources to resolve product complaints.

Product Complaint

ASEAN COSMETIC GMP MODULES

• Identify the key issues of product known or suspected to be defective and put in place a system, procedures and resources to institute product recall

Product Recall

ASEAN COSMETIC GMP MODULES

• Define the requirements for contract manufacturing and testing laboratory as well as establish the role and responsibilities between the contract giver and acceptor.

Contract Manufacturing Analysis

APPLICATIONS OF GMP: In Material receiving

a. Delivery

b. Sampling

c. Personnel

APPLICATIONS OF GMP: In Storage

a. Storage condition

b. Equipment

APPLICATIONS OF GMP: In Dispensing

a. Weighing

b. Equipment

c. Personnel

APPLICATIONS OF GMP: In Production

a. In time testing

b. Equipment

c. Personnel

APPLICATIONS OF GMP: In Filling

a. In time testing

b. Equipment

c. Personnel

APPLICATIONS OF GMP: In FG Storage to Release

a. Storage conditions

b. Logistics

c. Personnel

CHALLENGES OF GMP ON PATIENT SAFETY [2]

• Variability on interpretation and implementation of the guideline

• Qualified person

IMPACT OF GMP ON PATIENT SAFETY [4]

• Adverse reaction/event

• Defective product

• Fewer options/alternatives

• Cost

ROLE OF PHARMACISTS IN THE COSMETICS INDUSTRY [6]

• PRODUCT FORMULATION & DEVELOPMENT

• PRODUCT PROCESSING DEVELOPMENT

• PRODUCTION

• QUALITY ASSURANCE (QA)

• QUALITY CONTROL (QC

• REGULATORY AFFAIRS

Roles of Pharmacists under Product Formulation & Development [6]

• Formulate and establish product design.

• Conduct test protocols and procedures and product evaluation

• Transfer new technologies across a range of product formats.

• Write technical reports and cost estimates.

• Generate data to substantiate claims regarding the safety and efficiency of new products.

• Oversee the integration of new products with other commercial areas, including brand development, sales strategy, quality assurance, legal, marketing and manufacturing.

Roles of Pharmacists under Product Processing Development [5]

• Devise new processes, or refine existing ones, to optimise the manufacturing process.

• Plan, carry out and supervise process trials in laboratories, pilot plants or factories.

• Scale up the production process via plant trials, making changes to raw materials or components, and process parameters to ensure quality is maintained during large-scale production.

• Devise test methods to assess the production process,

• Validate new processes and show that they are an improvement.

Roles of Pharmacists under Production [5]

• Ensure that manufacturing processes run reliably and efficiently.

• Planning and organising production schedules.

• Assessing project and resource requirements

• Ensuring that health and safety regulations are met.

• Organising the repair and routine maintenance of production equipment.

• Organising relevant training sessions.

Roles of Pharmacists under QA/Quality Assurance [6]

• Plan, execute, and oversee product inspection and testing for quality and conformance to specifications and deliverables.

• Assist operations by tracking, documenting, and reporting quality levels as well

• Investigate reports of product quality issues and ensure resolution in accordance with company guidelines and regulatory requirements.

• Develop or update procedures for capture, investigation, and documentation of product complaints.

• Monitor risk-management procedures, maintain problem logs, and report issues to managers and product developers.

• Provide training and support to quality assurance team members that covers systems, policies. procedures, and core processes.

A pharmacist in quality assurance must employ _____ THINKING

FORWARD

Roles of Pharmacists under QC/Quality Control

● Inspection & Testing

● Documentation

● Quality Standards

● Defect Identification

● Sampling

● Reporting

● Calibration

● Root Cause Analysis (RCA)

● Compliance

● Process Improvement

● Supplier Evaluation

● Training

● Compliance Audits

Roles of Pharmacists under Regulatory Affairs [6]

● Ensure that a company's products comply with the regulations of the regions where they want to distribute them.

● Keep up to date with national and international legislation, guidelines and customer practices.

● Advise scientists and manufacturers on regulatory requirements.

● Company representative to the regulators and trade association.

● Liaise with, and make presentations to regulatory authorities.

● Business partnering with internal stakeholders.

A pharmacist under the ________ serves as the bridge between regulatory government and

the company

REGULATORY AFFAIRS