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Home > Manufacturing > liquid injectables

liquid injectables

1. Pre-Manufacturing Preparations

Confirm compliance with regulatory requirements (FDA, EMA, etc.)

Review and approve the Master Batch Record (MBR)

Validate and calibrate all necessary equipment

Ensure availability of raw materials and components

Conduct training for staff on procedures and safety

Here are some additional steps that could be included in the **Pre-Manufacturing Preparations** section of the New Liquid Injectables checklist

Conduct a risk assessment for the manufacturing process

Develop and review Standard Operating Procedures (SOPs) relevant to the manufacturing process

Ensure that the manufacturing environment meets cleanliness and contamination control standards (e.g., cleanroom certification)

Verify the integrity and functionality of utilities (e.g., water systems, HVAC) needed for manufacturing

Perform a risk analysis on suppliers and ensure their materials meet quality specifications

Establish and document a change control process for any modifications to the manufacturing process or equipment

Conduct a mock run or simulation to identify potential issues

Review and confirm the labeling and packaging specifications

Ensure that all safety equipment and emergency procedures are in place and communicated to staff

Set up a communication plan for all stakeholders involved in the manufacturing process

2. Manufacturing Process

Prepare cleanroom and controlled environment

Follow aseptic techniques during preparation

Weigh and measure ingredients accurately

Mix components according to MBR specifications

Perform in-process quality checks (pH, viscosity, etc.)

Here are some additional steps that could be included in the "2. Manufacturing Process" section of the New liquid injectables checklist

Ensure equipment is calibrated and functioning properly before use

Conduct a thorough cleaning and sanitization of all manufacturing equipment and surfaces

Verify the integrity of packaging materials prior to use

Maintain a controlled flow of materials to prevent cross-contamination

Document all batch production details in real-time

Monitor environmental conditions (temperature, humidity, airflow) throughout the manufacturing process

Conduct visual inspections of all materials and components before use

Implement a system for tracking and managing raw material lots and expiration dates

Utilize appropriate protective equipment for personnel during the manufacturing process

Perform a final inspection of the mixture before filling and packaging

Maintain a clear labeling system for all components and finished products

Ensure all waste materials are disposed of according to regulatory guidelines

Conduct a risk assessment prior to initiating the manufacturing process

3. Filling and Packaging

Ensure that filling equipment is sanitized and calibrated

Use sterile containers and closures for filling

Monitor filling line for volume accuracy

Label containers according to regulatory requirements

Conduct leak tests on filled containers

4. Quality Control

Perform final product testing (sterility, endotoxin, potency)

Document all quality control results

Review batch records for completeness and accuracy

Conduct stability testing as required

Ensure traceability of all materials used

5. Post-Manufacturing Procedures

Implement proper storage conditions for finished products

Conduct inventory checks and manage stock levels

Prepare documentation for distribution

Ensure compliance with shipment regulations

Review and analyze production data for continuous improvement

6. Documentation and Record Keeping

Maintain comprehensive records of all manufacturing steps

Document deviations and corrective actions taken

Archive all quality control results and test reports

Ensure documentation is accessible for audits

Regularly review and update standard operating procedures (SOPs)

7. Training and Personnel Management

Conduct regular training sessions for all personnel

Evaluate staff competency in manufacturing processes

Encourage reporting of non-conformances or anomalies

Maintain a training log for all employees

Foster a culture of quality and safety within the organization

This checklist serves as a comprehensive guide to ensure that all necessary steps are taken in the manufacturing of liquid injectables, maintaining quality and compliance throughout the process.

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