Pharmaceutical R&D, Scale-Up, and CAPA Processes Overview

Research and Development (R&D)

The department in a pharmaceutical company responsible for developing and formulating new drug products.

Lab Scale

The initial, small-scale production of a new drug formula, typically around 100 g.

Pilot Plant

The facility in a pharmaceutical industry where a lab scale formula is tested and transformed into a viable product on a larger scale before full production. It serves as the bridge between R&D and Production.

Pilot Batch

A medium-sized batch (e.g., 1000 g or 1 kg) produced in a pilot plant to determine if a new drug can be efficiently, economically, and consistently reproduced on a production scale.

Scale-Up (Production Scale)

The process of taking a formula that has been proven in a pilot plant and manufacturing it in large quantities (e.g., 10,000 g or 10 kg) for the market.

Batch Manufacturing Record (BMR)

A detailed written document prepared for every batch, containing actual data and step-by-step instructions for the entire manufacturing process.

Bill of Materials (BOM)

A part of the BMR that lists all raw and packaging materials needed for a batch, including material name, lot/reference number, and quantity. It is issued by the warehouse.

Batch Record (in BMR)

The first page of the BMR that contains all key information about the batch, such as batch number, batch size, composition, manufacturing/expiry dates, and storage conditions.

Manufacturing Process (in BMR)

The section of the BMR providing the step-by-step procedure for compounding, compression, encapsulation, coating, and packaging.

Line Clearance

A mandatory check performed before starting every manufacturing process to ensure the production line is clean, free from previous materials, and ready for the new batch.

Yield (in BMR)

The amount of product produced, which is calculated at the end of every stage to measure process loss. The final yield should not be less than 99.00%.

Equipment Cleaning Record (in BMR)

A checklist confirming the cleaning of all equipment used for a batch, including the previous product, batch number, and date of cleaning. It is checked by Quality Assurance.

Standard Operating Procedure (SOP)

A detailed, written instruction that describes exactly how to perform a specific process or activity to ensure consistency and quality.

Purpose of an SOP

To ensure operations are performed consistently, maintain quality control, ensure safety, comply with regulations, and serve as a training document.

Who writes and reviews SOPs?

Written by individuals knowledgeable about the activity, reviewed by others with appropriate training, and tested by users before being finalized.

Header (of an SOP)

The section at the top of every page containing the company name/logo, document title, SOP number, page number, department, and key dates (Issue, Review, Effectivity).

Issue Date (SOP Header)

The date from which the SOP is distributed to relevant departments.

Effectivity Date (SOP Header)

The date from which the SOP must be officially put into use.

Review Date (SOP Header)

The date by which the SOP must be revised or reviewed to ensure it remains current.

Supersedes (SOP Header)

Refers to the SOP number of the previous version that this document is replacing.

Signature Block (of an SOP)

Appears only on the first page and contains the signatures, typed names, and designations of the persons who Prepared, Verified, and Approved the SOP.

Body (of an SOP)

The main content of the SOP, containing the Objective, Scope, Responsibility, Procedure, and other key information.

Objective (SOP Body)

Defines the purpose of the SOP (the "why").

Scope (SOP Body)

Defines the area of application for the SOP (the "where" and "what").

Responsibility (SOP Body)

Refers to the people or roles that perform and monitor the procedure (the "who").

Procedure (SOP Body)

The detailed, step-by-step process on how the SOP should be performed (the "how").

Revision History (SOP Body)

A list of previous versions of the SOP indicating the reason(s) for revision.

Corrective and Preventive Action (CAPA)

A formal process to investigate, solve, and prevent the recurrence of problems by addressing their root causes.

Ultimate Purpose of CAPA

To ensure that a problem, once solved, can never be experienced again.

Step 1 of CAPA: Identification

Clearly and completely defining the problem, including its source, a detailed explanation, and all available evidence.

Step 2 of CAPA: Evaluation

Assessing the potential impact and risk of the problem to determine the need for and level of action required.

Step 3 of CAPA: Investigation

Creating a written plan to investigate the problem, including the objectives, strategy, and assignment of responsibility.

Step 4 of CAPA: Analysis

Using the investigation plan to collect data and identify the primary root cause of the problem, as well as any contributing causes.

Step 5 of CAPA: Action Plan

Developing a detailed plan that lists all tasks required to correct the problem and prevent its recurrence, including assigned responsibilities and deadlines.

Step 6 of CAPA: Implementation

Executing the action plan by initiating, completing, and documenting all the required tasks.

Step 7 of CAPA: Follow-up

Evaluating the actions taken to verify their successful completion and to assess their effectiveness in permanently solving the problem.