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PHARMACEUTICAL DEPARTMENT – OVERVIEW
A Pharmaceutical Department (in a pharma company or manufacturing site) generally covers all functions involved in the development, manufacturing, quality control, quality assurance, supply, and compliance of pharmaceutical products.

1. Production Department

Responsible for:

Manufacturing of drug products (tablets, capsules, liquids, injectables, etc.)

Handling raw materials and components

Maintaining equipment and facility hygiene

Implementing GMP practices on the shop floor

Batch manufacturing and packaging operations

2. Quality Control (QC) Department

Responsible for:

Testing raw materials, in-process samples, finished products

Stability testing

Microbiological testing (if applicable)

Analytical method validation & instrumentation

Ensuring products meet specifications before release

3. Quality Assurance (QA) Department

Responsible for:

Documentation control (SOPs, BMR/BPR)

Batch record review & product release

Change control, deviations, CAPA

Internal audits & compliance

Validation and qualification oversight

GMP training programs

4. Research & Development (R&D)

Includes:

Formulation development

Analytical method development

Technology transfer

Pilot-scale trials

Innovating new products and improving existing ones

5. Regulatory Affairs

Handles:

Dossier preparation (CTD/ACTD)

Product registration

Regulatory submissions to authorities (FDA, EMA, WHO, etc.)

Compliance with regulatory updates and guidelines

6. Engineering & Maintenance

Ensures:

Proper functioning of utilities (HVAC, water systems, compressed air)

Equipment qualification & preventive maintenance

Calibration of instruments

Automation, safety systems

7. Supply Chain / Warehousing

Covers:

Procurement of raw materials & packaging materials

Inventory management

Distribution of finished products

Cold chain management (if applicable)

Vendor qualification

8. Pharmacovigilance

Monitors:

Adverse drug reactions (ADR)

Post-marketing surveillance

Risk management plans

9. Safety, Health & Environment (SHE)

Focuses on:

EHS compliance

Handling of hazardous chemicals

Waste management

Occupational safety