PRESENTED BYSYED MASUDUR RAHMAN DEWAN, B. PHARMDEPARTMANT OF PHARMACYNOAKHALI SCIENCE AND TECHNOLOGY UNIVERSITYE-MAIL: masud_nstu@yahoo.com

Manufacturing- Bulk and Sterile

Control•• Budgetary controlBudgetary control

– To regulate the economic aspects of the program.– To regulate the economic aspects of the program.

•• Quality ControlQuality Control– To govern the quality, purity and strength of the manufactured product

Budgetary Control

• Manufacturing Requirements• Material Requirements• Material Requirements• Manufacturing Capacity• Manufacturing Equipment and Its Sources• Manufacturing Staff• Operating Costs

Manufacturing Requirement

• Staff’s present prescribing pattern• Carefulness of the Pharmacist• Proper estimation of

manufacturing productsmanufacturing products

Material Requirement

• Raw materials–Containers–Labels–Labels–Ancillary materials–Filter paper–Filter pad–Boxes and special labels

MaterialRequirement (contd.)

MaterialRequirement (contd.)

• Taking formula and determination of quantity of chemical required for final production

• Putting data on a summary sheet• Putting data on a summary sheet• Dividing the budget period into four quarter

allowing the purchasing group to utilize good purchasing techniques.

Manufacturing Capacity

• Availability of Pharmacist to him• Capability of the machineries for the • Capability of the machineries for the

production

Manufacturing Equipment and its source

• Equipments varies from one institution to another

• Depends on • Depends on – Length of time for production– Availability of personnel– Availability of physical facilities

Manufacturing Staff

• The lower the personnel, the lower the overall manufacturing cost

• Trained personnel needed– May be trained by pharmacists about bottling,

filtering, labeling, etc

Operating Cost

• Operating costs can be described as the expenses which are related to manufacturing program in hospital pharmacies.

• Consists of– Direct labor– Cost of material– Indirect cost

Quality Control

• Quality control or statistical quality control is the application of statistics for control of sizes, weights and other physical characteristics of articles undergoing mass production. articles undergoing mass production.

• But is case of hospital, quality control will ensure the integrity of the label which is done by developing a series of checks and laboratory analysis.

Good Manufacturing Practice Regulations Good Manufacturing Practice Regulations For Hospital

Organization and Personnel

• Responsibilities of quality control unit

• Personnel Qualifications

• Personnel Responsibilities

• Consultants

Buildings and facilities

• Design and construction features • Lighting• Ventilation, Air filtration, Air heating and cooling• Plumbing• Plumbing• Sewage and refuse• Washing and toilet facilities• Sanitation• Maintenance

Hospital Equipment

• Equipment design, design, size and location

• Equipment construction

• Equipment cleaning and maintenance

• Automatic, Mechanical, and Electronic

Equipment

Control of components and drug product containers and closers

• Receipt and storage of untested components, drug product containers, and closures.

• Testing and approval or rejection of components, drug product containers, and closures.product containers, and closures.

• Use of approved components, drug product containers and closures.

• Resisting of approved components, drug product containers and closures.

• Rejected components, drug containers and closures.

Production and Process Controls

• Written Procedures and deviation• Charge in of components• Calculation of yield• Equipment identification• Equipment identification• Sampling and testing of in-process materials and

drug products• Time limitations on production• Control of microbiological contamination• Reprocessing

Holding and Distribution

• Warehousing procedures• Distribution procedures.