Manuf Lab

• Labelling parameters required for inner label:

  • Product Name
  • Dosage Form
  • Name of Active Ingredient(s)
  • Strength of Active Ingredient(s)
  • Batch Number
  • Manufacturing Date
  • Expiration Date
  • Route of Administration
  • Storage Condition
  • Country’s Registration Number (if applicable)
  • Name and Address of Marketing Authorization Holder
  • Name and Address of Manufacturer
  • Special Labelling (if applicable)
  • Warning (if applicable)
• Departments in a Manufacturing Company:

  • Production: turn inputs to outputs
  • Quality: reduce inefficiencies, operation errors, and prevent product defects
  • Operations and Marketing: purchase, ensures availability and delivery of materials needed by each department
  • Research and Development: innovations
• Personnel in a Manufacturing Company:

  • CEO
  • QA
  • QC
  • Production Manager
  • Warehouse Manager
• Batch Manufacturing Record:

  • Basic records for ensuring quality and regulatory requirements are achieved
  • Written document from a batch prepared during the pharmaceutical manufacturing process
  • Contains actual data and step-by-step process
• Master Formula:

  • Master document for any pharmaceutical product
  • Contains all information about the manufacturing processes of the product
  • Prepared by the Research and Development team
  • Other documents (BMR and BPR) are prepared during the manufacturing process
• Batch Packaging Record:

  • Contains all information about the packaging process of the batch and requirement of GMP documentation
  • Must contain everything about the packaging process
  • Includes type of container, packaging equipment, net weight
• Quality Control Record:

  • Reports containing recorded data of all quality tests, standards, and specifications