Departments in the Pharmaceutical Industry

This Article is important for Fresher, Experienced employee and Employer (Entrepreneur)

In this article, we will understand the Basic Functions of Key departments of the Pharmaceutical Organization.

• The requirement of the Department in Industry:

• The Key Departments in the pharmaceutical Industry:

• Basic Functions of key departments;

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The requirement of the Department in Industry:

Based on the Business model of the Company; the workflow should be established.

We will understand by taking the example of a small company who have limited staff (employee); This company has to distribute the work to the employee in such a way so employees can accomplish the work smoothly. The company should not create so many departments at this stage, but as the company is growing they have to reorganize the workflow and departmental role & responsibilities.

The workflow and people (employee) should be organized for efficient utilization of manpower and it should be reviewed periodically; that is the real meaning of the word “Organization”

The Key Departments in the pharmaceutical Industry:

• Quality Assurance (QA)

• Quality Control (QC)

• Microbiology (Micro)

• Research / Formulation and Development (R&D or F&D)

• Analytical Method Development Laboratory (ADL)

• Warehouse (Stores)

• Production and Packing

• Engineering (Utility)

• Human Resources (HR) and Admin

• Environmental Health and Safety (EHS)

• Information Technology (IT)

• Purchase

• Accounting

• Marketing / Business Development

• Supply Chain Management

Basic Functions of the Key Departments:

The functions may vary based on organizational requirements; however, the following basic functions are provided for understanding.

Note: Here I am not providing the definition of the department, the text is content basic functions as per industrial practice.

The detailed information of the functions will be provided in subsequent Articles and/or Short Notes.

Quality Assurance (QA):

This department is an important department of the organization as this department is a requirement of the regulation.

Quality assurance is providing guidance and inculcating the people for the development of quality culture in the organization

The few activities are as follows;

• Vendor Qualification

• Service agency Qualification

• Equipment Qualification

• Analyst Qualification

• Instrument Calibration

• Process Validation

• Cleaning Validation

• Quality Management System

• Change control

• Deviation Control

• Approval of Analytical Method Validation

• Market Complaint Investigation

• Risk Management

• Corrective Action and Preventive Action

• Out of specification investigation and approval

• Standard operating procedure development and approval

• Stage wise in-process testing

• Approval of method of analysis for quality control laboratories

• Training of the employee as per good manufacturing practice requirement

• Document and data control

• Internal Audit

• Batch release for the market

• Product stability

All the activity where product quality is directly or indirectly involved

Quality Control (QC):

QC function is related to analysis as per validated and approved Method and the result shall be compared with the pre-defined approved specification.

The few activities are as follows;

• Maintain laboratory as per Good Laboratory Practice (GLP)

• Analytical Method Validation

• Preparation of Specification and Method of Analysis

• Instrument Calibration

• Analysis of Raw Material, Packaging Material, Inprocess sample, Finished Goods sample, Stability Sample, Market Complaint Sample, Other samples, etc.

• Control Sample Storage

• Stability Study

• Out of Specification Investigation

• Preparation of Certificate of Analysis (CoA)

Microbiology (Micro):

Microbiology department function is also related to Microbiological analysis/testing as per validated and approved Method and the result shall be compared with the pre-defined approved specification.

The Functions are common between QC and Micro like…

• Maintain laboratory as per Good Laboratory Practice (GLP)

• Analytical Method Validation

• Preparation of Specification and Method of Analysis

• Instrument Calibration

• Analysis of Raw Material, Packaging Material, Inprocess sample, Finished Goods sample, Stability Sample, Market Complaint Sample, Other samples, etc.

• Out of Specification Investigation

This department is considered as a sub-department of QC in many organizations.

Research / Formulation and Development (R&D or F&D):

The R&D department is involved in research work; search for a new molecule, synthesis and modification of known molecules or some methods to increase productivity by adopting different techniques.

This department is required Highly Knowledgeable candidate, many organizations have their R&D Department.

The F&D department is working on the development of product formulation.

Product development is an essential and first part of the product life cycle.

This department has to carry out the development of a stable product and transfer it to the production department for routine commercial manufacturing

Analytical Method Development Laboratory (ADL):

An analytical method is required to analyze any material or product.

This department is working on the development of the analytical method which is suitable for the instrument available in the laboratory,

The analytical method should be developed considering the parameter of method validation

Typical validation parameters recommended by FDA, USP, and ICH are as follows:

1. Specificity

2. Linearity and Range

3. Precision

   1. Method precision (Repeatability)

   2. Intermediate precision (Ruggedness)

4. Accuracy

5. Solution stability

6. Limit of Detection (LOD)

7. Limit of Quantification (LOQ)

8. Robustness

Warehouse (Stores):

It includes storage of Raw material, Packaging material, ancillary material, intermediate material engineering material, finished goods

The basic functions are as follows;

• Maintain Good Storage Practice

• Receipt and verification of the material

• Segregation of the material at various stages like Quarantine, Under test, Approved Reject

• Maintain the recommended storage condition

• Reconciliation of the material and stock maintenance

• Dispensing of the material

Most of the audit starts from Warehouse; as this department is the starting point as per material flow.

Production and Packing:

This department is the center of business, other departments are supporting or service departments

The basic functions are as follows;

• To maintain Good Manufacturing Practices

• Manufacturing of the product

• Manpower Handling

• Maintain Quality of the product at the various production stages

• Final Product packing

• Preparation of Batch manufacturing and Packing Record

• Maintain other records (e.g. Logbook) as per GMP requirement

Engineering (Utility):

This department provides support to increase productivity, Decrease cost by utilizing engineering knowledge.

The Basic Functions of this department are as follows;

• Follow the Good Engineering Practice

• Maintenance of Building / Facility

• Preventive Maintenance of Equipment/Instrument

• Breakdown Maintenance

• The constant supply of required utility

• Water System Handling

• HVAC System Handling including AHU, Cooling Tower, Chiller, etc.

• Manpower Handling

Human Resources (HR) and Admin:

This department play important role in the organization, as HR is dealing with employee (human).

You can purchase machinery by paying money, but you have to retain humans with you with emotion; you cannot purchase by money for a longer time.

The basic functions of this department are as follows;

• Maintain relation with personnel as a representative of management

• To follow Act and Rule as per law of land (factory Act, Labour Law, etc.)

• Recruitment of Manpower

• To aware employee about Personnel Hygiene

• Medical checkup of the employee

• Maintain a statutory record of the employee like Attendance, Leave, PF, ESI, etc.

Environmental Health and Safety (EHS):

This department is taking care of ...

Corporate social responsibility (CSR), pertains to people and organizations behaving and conducting business ethically and with sensitivity towards social, cultural, economic, and environmental issues

Employee Safety at Workplace

The basic functions of this department are as follows

• Employee safety at the workplace

• Provided training related to fire safety and other safety at the workplace

• Provide Fire fighting training

• Provide first aid training

• Provide training on the emergency evacuation plan to employees and visitors

• Conduct mock drill

• Environmental safety

Information Technology (IT):

Now a days electronic data is ecencial part of the business.

This department is taking care of following things as per Good Manufacturing Practice (GMP) requirement,

• Maintenance of IT infrastructure

• Data buckup

• Data security

Purchase:

This department is related to commercial operation however, Some Good Manufacturing Practice (GMP) requirement should be taken care by this department as follows,

• Vendor identification

• Procurement of the required material from the approved vendor list

• Ensure material availability as per production planning

• Communicate and coordinate with vendor for Vendor Audit and at the time of complaint regarding the material or the product which is manufactured using the material supplied by the vendor.

Accounting:

This department is related to commercial operation.

The basic functions are as follows,

To maintain the commercial transactions

• Maintain accounting of the same

• Costing of the batch

Supply Chain Management:

This department is responsible for maintain recommended storage condition during transit and storage up to distribution. the storage condition is directly impact to the Product Quality.

In pharmaceutical it is important to maintain track record of the quantity distributed, it is required whenever product needs to be recalled from the market in any unfavorable condition.

The basic functions of the department are as follows,

• Follow the good distribution practice as per regulatory requirement

• Arrange transportation from factory to customer destination

• Tracking of the product wise and customer wise distribution

• provide the data to the quality assurance department as and when required.

• Coordinate with customer and Quality Assurance for Mock Recall of actual Product Recall

I have tried to cover Key departments information in this article, however, the detailed information will be provided in subsequent Article and Short Note.

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