GMP : Tablet Manufacturing Technology Industry Certification

Description

Drug manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs as part of the pharmaceutical industry. The process of drug manufacturing can be broken down into a series of unit operations, such as milling, granulation, coating, tablet pressing, and others.

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The design and manufacture of pharmaceutical tablets is a complex multi-stage process whereby formulation scientists ensure that the correct amount of drug substance in the right form is delivered at the appropriate time, at the proper rate and in the desired location with its chemical integrity protected to that point. Most drug substances do not possess the required properties which give satisfactory flow from the hopper to the die cavity of tablet presses. As a result, they are subjected to pre-treatment either alone or in combination with suitable excipients to form free-flowing granules that lend themselves to tabletting.

A tablet is a pharmaceutical oral dosage form (Oral Solid Dosage, or OSD) or solid unit dosage form. Tablets may be defined as the solid unit dosage form of medicament or medicaments with suitable excipients.

Tablets are prepared either by molding or by compression. Tablets are commonly manufactured by wet granulation, dry granulation or direct compression.

These methods may be considered to consist of a series of steps (unit processes) – weighing, milling, mixing, granulation, drying, compaction, (frequently) coating and packaging.

Unit Operations in tablet manufacturing

Numerous unit processes are involved in making tablets, including

1. Particle size reduction and sizing,

2. Blending,

3. Granulation,

4. Drying,

5. Compaction,

6. and (frequently) Coating.

Various factors associated with these processes can seriously affect content uniformity, bioavailability, or stability.

Primary goals of tablet manufacturing process

The primary goals include:

1. To formulate tablets that are strong and hard to withstand mechanical shock encountered during manufacturing, packing, shipping, dispensing and use.

2. To formulate tablets that are uniform in weight and in drug content.

3. To formulate tablets that are bioavailable according to indication requirements.

4. To formulate tablets that are chemically and physically stable over a long period of time.

5. To formulate tablets that have elegant product identity which is free from any tablet defects.

Factors that influence the choice of manufacturing process used during tablet formulation

In general, the choice of formulation process employed during tablet manufacture is dependent upon such factors as:

1. Compression properties of the Active Pharmaceutical Ingredient (API)/ drug substance.

2. Physical and chemical stability of the API during the manufacturing process.

3. Particle size of the formulation ingredients.

4. Availability of the necessary processing equipment.

5. Cost of the manufacturing/formulation process.

Personnel requirements during manufacture of pharmaceutical tablets

• Production pharmacists/ supervisors

• Manufacturing chemist

• Analytical chemist

• Quality assurance manager

• Machine operators

• Mechanics

In addition to the job-specific responsibilities of these personnel, all manufacturing employees must be versed and trained in Current Good Manufacturing Practices (CGMPs) and in the appropriate Standard Operating Procedures (SOPs) governing their area.

Area required for manufacture of tablets

• Raw material warehouse

  • Receiving quarantine

  • Approved raw material section

• Dispensary

• Production room

  • Mixing, Granulation and Drying Section

  • Tablet Punching Section

  • Coating Section

• Quality control section

• Packaging Section.

QUALITY CONTROL EQUIPMENTS

• Friabilator

• Disintegration apparatus

• Hardness Tester

• Vernier Caliper

In This Course Students will learn above pharmaceutical aspects/approach for tablet manufacturing in GMP Area.

Students-

• Diploma in pharmacy

• B. Pharmacy

• M. Pharmacy

• M. Sc Students

• Freshers & Employees

• Students seeking oportunitirs for Pharma job career

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