Criar um checklist completo, abrangendo todos os requisitos das RDC's 47 e 48 do Brasil,

General Requirements

Perform a thorough review of RDC's 47 and 48 to understand all requirements

Read RDC's 47 and 48 carefully
Make notes of all the requirements mentioned
Understand the purpose and intent of each requirement

Ensure compliance with all applicable sections and sub-sections of the RDC's

Identify the relevant sections and sub-sections in RDC's 47 and 48
Cross-reference the requirements with the applicable sections and sub-sections
Ensure that all requirements are addressed and met

Keep track of any updates or revisions to the RDC's and incorporate them into the checklist

Regularly check for updates or revisions to RDC's 47 and 48
Record any changes or updates in a separate document
Update the checklist to include the new requirements or revisions

Facility Requirements

Check if the facility meets all the necessary infrastructure requirements specified in the RDC's

Verify if the facility has adequate space, ventilation, lighting, and cleanliness

Ensure that the facility has proper storage conditions for products, including temperature control, segregation, and labeling

Equipment Requirements

Identify all equipment required for the specific activities mentioned in the RDC's

Check if the equipment is properly calibrated, validated, and maintained

Ensure that the equipment is suitable for the intended use and meets all safety requirements

Personnel Requirements

Verify if all personnel involved in the activities are properly trained and qualified

Check if the personnel have the necessary knowledge and skills to handle the products and perform their tasks

Ensure that there are enough personnel to carry out the required activities effectively

Documentation Requirements

Review all documentation requirements mentioned in the RDC's

Ensure that all necessary documents, such as Standard Operating Procedures (SOPs), Batch Records, and Quality Control documents, are in place and up to date

Verify if there is a proper document control system in place to manage and track all required documentation

Quality Control Requirements

Check if there is an effective quality control system in place to ensure product quality and compliance with the RDC's

Review the requirements for quality control testing, sampling, and analysis

Verify if there are proper procedures for handling and reporting any deviations or non-conformities

Product Requirements

Identify all specific requirements for the products mentioned in the RDC's

Verify if the products meet all quality, safety, and labeling requirements specified in the RDC's

Ensure that there are proper procedures for storage, handling, and distribution of the products

Recordkeeping and Reporting Requirements

Check if there is a proper recordkeeping system in place to document all activities, including production, quality control, and distribution

Verify if there are procedures for reporting any adverse events or product complaints

Ensure that all required records are maintained and accessible for inspection

Auditing and Inspections

Verify if there is a procedure for internal audits to assess compliance with the RDC's

Check if there is a schedule for external inspections and ensure that all preparations are made accordingly

Ensure that there is a process for addressing any findings or recommendations from audits or inspections

Continuous Improvement

Encourage a culture of continuous improvement by regularly reviewing and updating the checklist based on new regulations, industry best practices, and lessons learned

Seek feedback from stakeholders and incorporate their suggestions for improving compliance with the RDC's

Continuously monitor and evaluate the effectiveness of the checklist in ensuring compliance with the RDC's