Industrial Pharmacy II:Advanced Drug Production Technology & GMP

Correlation of in-vitro and in-vivo tests. Examples of correlation of in-vitro and in-vivo data of some drugs, e.g. aspirin, digoxin, grieseofluvin and oxytetracycline tablets and capsules. Problems involved in obtaining perfect correlation. Regulatory affairs and agencies and clinical trials.

Sustained vs. controlled drug release of pharmaceuticals: Types, problems and advantages. Methods of obtaining sustained release and factors affecting the sustained release of the drugs. Solid and liquid sustained release preparations including emulsions, suspensions and parenteral products. Micro/nano-encapsulation-applications, problems, techniques and equipment. Modern pharmacokinetics and biopharmaceutics approaches in sustained release formulations, delivery and control.

cGMP. General introduction with glossary of terms. General inspection, quality assurance and quality control procedures and sampling. Personnel and training. Building and environmental hygiene. Planning formula and manufacturing instructions. Handling of starting materials, packaging materials, intermediate products, and finished products. Standard and batch packaging and labeling instruction. Control of packaging materials and packing operations. Supervision of production, storage, transport and distribution. Manufacture and control of sterile medicinal products including premises processing environment, aseptic area and equipment. Cross contamination, etc.

Pilot plant scale up techniques: General and product considerations. Solid, semi-solid and liquid dosage forms. Approach to pharmaceutical process validation, validation of new raw materials, processing equipment, plant services, manufacturing processes, cleaning processes, checklist of validation and control documentation, control charts, organizing of validation and pilot scale up in process validation.  

Levels/scales of pharmaceutical manufacturing and investment (small, medium, large, multinational, primary and auxiliary). International Certification Schemes; Introduction to the International Conference on Harmonization (ICH), ISO, Product dossier, CTDs, etc.  Intellectual Property and Patent Rights of Product. Pharmaceutical quality systems. Quality Management Systems (QMS), Quality audit and quality by design Product Launch; Post Market Surveillance. Pharmaceutical packaging, packaging materials, packing regulating bodies, Guidelines on packaging for pharmaceutical Products, Quality specifications, Packaging materials and closures. Production planning and management; Batch versus continuous production systems, Process Analytical Technology.