Contents:

(1) GMP - SOPs for Finished Dose This CompuPharma GMP Module is ideal for both new and existing employees in the Pharmaceutical Industry, who are required to work according to the regulations of 21 CFR 210 and 211, or Eudralex Volume 4. The Module describes what an SOP is, why SOPs must be followed in Finished Dose plants and what information they should contain. Objectives: - Define Standard Operating Procedures - Explain why SOPs are used - List the rules that must be followed when using SOPs - List the types of information contained in SOPs (2) GMP - Records for Finished Dose This CompuPharma GMP Module is ideal for both new and existing employees in the Pharmaceutical Industry, who are required to work according to the regulations of 21 CFR 210 and 211, or Eudralex Volume 4. The Module explains 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. Objectives: - Define what records are - Describe the general rules for completing records - Explain what a documentation system is and why manufacturing companies use them - List the information that must be entered on various records - List the types of records required in a finished dose manufacturing company (3) Personnel and Training This CompuPharma GMP Module is ideal for both new and existing employees in the Pharmaceutical Industry, who are required to work according to the regulations of 21 CFR 210 and 211, or Eudralex Volume 4. The Module describes GMP requirements concerning personnel, training, clothing, hygiene and health. Objectives: - Describe the hygiene and health responsibilities of employees in the pharmaceutical - industry - Explain the importance of training in the pharmaceutical industry - Explain why protective clothing is so important in the pharmaceutical industry - List the areas of personal responsibility for employees in the pharmaceutical industry (4) Warehousing This CompuPharma GMP Module is ideal for both new and existing employees in the Pharmaceutical Industry, who are required to work according to the regulations of 21 CFR 210 and 211, or Eudralex Volume 4. The Module is an introduction to Pharmaceutical warehousing. Covers warehouse functions, GMP in the warehouse and QC status for materials and products. Objectives: - Describe how materials are received into and issued out of a warehouse - Describe the purpose and functions of a warehouse - Describe the purpose of a Warehouse Management System - Explain the importance of product distribution records - List and explain the three QC status categories of materials and products in a warehouse - Name the warehouse storage conditions that must be controlled and their importance (5) Cleaning of Equipment This CompuPharma GMP Module is ideal for both new and existing employees in the Pharmaceutical Industry, who are required to work according to the regulations of 21 CFR 210 and 211, or Eudralex Volume 4. The Module describes different equipment cleaning methods used in the Pharmaceutical Industry. Objectives: - Describe two sampling methods that are commonly used in a pharmaceutical plant - Explain why cleaning of equipment is carried out in a pharmaceutical plant - List the important information that is contained in a Cleaning SOP - Name and describe the three types of cleaning methods used in a pharmaceutical plant - Name and describe the two main categories of equipment - State the advantages and disadvantages of each cleaning method (6) Sampling This CompuPharma GMP Module is ideal for both new and existing employees in the Pharmaceutical Industry, who are required to work according to the regulations of 21 CFR 210 and 211, or Eudralex Volume 4. The Module describes the different types of sampling methods found in the Pharmaceutical Industry. Also includes rules that should be followed when sampling materials. Objectives: - Describe the characteristics of a sample container - Describe the consequences of incorrectly taking samples - Explain the terms "Reserve Samples" and "Stability Samples" - Explain why sampling is important in a pharmaceutical plant - List the important information that is contained in a Sampling SOP - Name the items that are sampled in a pharmaceutical plant - Outline the information required on a sample label (7) Buildings & Facilities This CompuPharma GMP Module is ideal for both new and existing employees in the Pharmaceutical Industries, who are required to work according to the regulations of 21 CFR 210 and 211, or Eudralex Volume 4. The Module explains the GMP design requirements for a manufacturing facility. This includes the product flow, environmental controls, cleaning and sanitization. Objectives: - Describe the concept of product flow - Describe why a proper plumbing system is necessary - Explain how pharmaceutical plants are designed - Explain the importance of good cleaning, sanitation and maintenance procedures - List and explain the environmental controls employed in pharmaceutical plants (8) IT Use in Regulated Industries This CompuPharma Module is ideal for people who work in the API, Biotech or Pharmaceutical sectors and are governed by the Rules of the FDA's 21 CFR11 and the Eudralex Annex 11. The Module explains the basics of Information Technology and Good Computer Practice and looks at how IT is used in regulated industries. Objectives: - Define computer network, LAN and WAN - Define Internet, e-mail, intranet and World Wide Web - Describe the importance of computer security in regulated industries - Describe the various uses of IT in regulated industries - Distinguish between computer software and computer hardware - Explain what is meant by the term 'Information Technology' - List and describe the rules for good computer practice