Standard Operating Procedures (SOPs) and Records Are Critical in Ensuring That Operators Are Working in Compliance With CGMP - E-Learning Course: Advanced GMP For Solid Dose Operators (Certified).

DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/reports/c37023) has announced the addition of E-Learning Course: Advanced GMP for Solid Dose Operators (Certified) to their offering.

Having grasped the basics of GMP in "Essential GMP for Solid Dose Operators", an operator now needs to move on to more advanced GMP concepts. Advanced GMP for Solid Dose Operators covers everything a trainee needs to know about more demanding CGMP topics such as SOPs, completing records, cleaning of equipment, QC status, use of computers, etc.

Standard Operating Procedures (SOPs) and records are critical in ensuring that operators are working in compliance with CGMP. This course begins by explaining why SOPs must be followed in solid dose facilities and what information they should contain. It also describes the proper completion of records in solid dose manufacturing including production records, equipment records, records of materials and laboratory sample records.

Proper labelling and cleaning of equipment are vital in avoiding mix-ups and product contamination. This course takes an in-depth look at both of these areas - the importance of accurate labelling is stressed, along with label distribution and reconciliation, while different equipment cleaning methods used in the pharmaceutical industry are also explored.

The course continues with CGMP in the warehouse and Quality Control (QC) status of materials and products. The CGMP design requirements for manufacturing facilities are also examined with emphasis on product flow, environmental controls, cleaning and sanitization. Finally, the basics of Information Technology and Good Computer Practice are explained.

Topics covered:

-- GMP -- SOPs for Finished Dose

-- GMP -- Records for Finished Dose

-- Personnel and Training

-- Warehousing

-- Cleaning of Equipment

-- Sampling

-- Buildings and Facilities

-- Process Routine

-- IT Use in Regulated Industries

Certificate

There is a 16 question assessment associated with each lesson within the Course and we offer a Certificate Service in which Users who achieve 100% in the assessment associated with each Lesson of a Course are deemed to have passed the Course, and are posted a Certificate.

-- GMP - SOPs for Finished Dose

What an SOP is, why SOPs must be followed in Finished Dose plants and what information they should contain.

-- GMP - Records for Finished Dose

How to complete records required for Finished Dose manufacture. Records include records of materials, production records, equipment records, laboratory records, production review and distribution records.

-- Personnel and Training

Describes GMP requirements concerning personnel, training, clothing, hygiene and health.

-- Warehousing

Introduction to Pharmaceutical warehousing. Covers warehouse functions, GMP in the warehouse and QC status for materials and products.

-- Cleaning of Equipment

Different equipment cleaning methods used in the Pharmaceutical Industry.

-- Sampling

The different types of sampling methods found in the Pharmaceutical Industry. Also includes rules that should be followed when sampling materials.

-- Labeling

The importance of accurate labeling in a pharmaceutical plant. What must be contained on a label, along with label distribution and reconciliation.

-- Buildings & Facilities

The GMP design requirements for a manufacturing facility. This includes the product flow, environmental controls, cleaning and sanitization.

-- Process Routine

Personal Protective Equipment (PPE) and an introduction to process documentation and a generic weighing procedure.

-- IT Use in Regulated Industries

Explains the basics of Information Technology and Good Computer Practice and looks at how IT is used in regulated industries.

For more information visit http://www.researchandmarkets.com/reports/c37023