Annex 9 – Manufacture of Liquids, Creams and Ointments

Description

PIC/S Annex 9 – Manufacture of Liquids, Creams and Ointments

Annex 9 – Manufacture of Liquids, Creams and Ointments

Initial and ongoing GMP training of personnel is a legal requirement for manufacturers and distributors of therapeutic products. PIC/S Annex 9 GMP Training: This eLearning course for PIC/S Annex 9 covers the specific GMP requirements for the manufacture of liquids, creams and ointments for human use.

Intended audience

• This GMP compliance course is suitable for a global audience.
• It will suit a variety of personnel roles in manufacturing, packaging/labelling and distribution settings, from production personnel through to Quality Managers and Pharmaceutical Engineers.

Product types covered by PIC/S Annex 9

The Good Manufacturing Practice (GMP) guidance in PIC/S Annex 9 is applicable to a wide variety of topical-use therapeutic products, including:

• Combination cosmetic-therapeutic products
• Products intended to treat or mitigate health conditions such as eczema, psoriasis, hives, dandruff, excess perspiration, cold sores, etc.
• Sunscreens/sun protection products
• Medicated toothpaste products
• Etc.

This GMP Compliance eLearning course will help learners understand regulatory compliance requirements & personnel responsibilities relevant to the manufacture of liquids, creams and ointments; based on guidance in PIC/S Annex 9.

PIC/S GMP Training Online Course Title:  Manufacture of liquids, creams and ointments – online GMP Annex 9 Certificate Course.

GMP rules & regulations for liquids, creams and ointments

The manufacture of liquids, creams and ointments (e.g., products offering sun protection or which are intended to prevent or treat a disease or health condition such as psoriasis, eczema, dandruff, etc.) must be performed in accordance with the practices described in the PIC/S Guide to GMP where applicable including Annex 9.

This training module is intended to provide an understanding of the specific requirements outlined in Annex 9 relating to equipment, environmental considerations and production requirements for the manufacture of liquids, creams and ointments intended for therapeutic use.

Objectives of this GMP Certificate Course for Annex 9 include but are not limited to:

• Equipment and environmental considerations
• Production requirements
• Controls
• GMP compliance for manufacturing

This course is best completed in conjunction with other product-relevant GMP eLearning courses including but not limited to:

• Good Recordkeeping Practice (GRK)
• Good Warehouse Practice (GWP)
• Good Distribution Practice (GDP)
•  GMP training for Managing Deviations and Non-Conformances
• GMP training for implementing CAPAs 
• GMP training for Managing Recalls of Medicines, Medical Devices, and other Therapeutic Goods
• Managing Complaints (GMP Guidelines)
• GMP training for Pharmacovigilance Guidelines
• Recalls of Therapeutic Goods (Medicine Recalls, Medical Device Recalls)

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PIC/S Annex 9 covering GMP requirements for the Manufacture of Liquids, Creams and Ointments – Learn GMP compliance via eLearning!

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GMP Certificate Course: PIC/S GMP Annex 9

GMP Certificate of Completion

After successful completion of online GMP training courses (including individual courses available in a training bundle), the trainee will receive a personalised GMP Certificate of Training that meets regulatory GMP requirements.

The Certificate of Completion for this GMP education topic “PICS Annex 9 Manufacture of Liquids, Creams and Ointments” can be downloaded, printed, and attached to personnel files, GMP training program records, and the individual’s CV.