cgmp chapt 4

What must be done upon receipt of untested components, containers, and closures (211.82)?

• Visually examined for labeling, damage, or contamination.

• Stored under quarantine until tested or examined.

What does Section 211.84 require before using components or containers?

• Sampled, tested, or examined.

• Withheld from use until approved and released.

• Representative samples must be collected according to a standard procedure.

What is the First In, First Out (FIFO) principle in Section 211.86?

The oldest approved stock must be used first.

When should retesting of approved components occur, as per Section 211.87?

After long storage periods or exposure to conditions (e.g., air, heat) that may affect quality.

How must rejected components, containers, or closures be handled (211.89)?

They must be quarantined to prevent use in manufacturing.

What are the requirements for drug product containers and closures in Section 211.94?

• Must not be reactive, additive, or absorptive.

• Must be clean, sterilized, and free of pyrogens.

Why is container and closure analysis important?

• Prevent degradation reactions.

• Protect the drug from environmental conditions.

• Do not act as additives or absorbents.

What should SOPs contain according to 211.100?

• Objectives of the procedure.

• Detailed steps and included elements.

• Designated reviewers and approvers.

What is required for SOP updates?

• Changes must follow a change control procedure.

• Outdated copies must be replaced, and staff must be retrained.

What is specified in Section 211.101 about the charge-in of components?

• Batch formulation must have not less than 100% of labeled active ingredients.

• All materials must be weighed, measured, and verified by a second person.

• New containers must be properly identified.

What does Section 211.103 require for the calculation of yield?

• Actual and theoretical yields must be calculated and verified by a second person.

• Yield must be calculated at the end of each manufacturing phase.

What is outlined in Section 211.105 about equipment identification?

• All equipment, containers, and lines must be clearly identified with:

  • Contents.

  • The phase of processing.

What are the requirements for in-process sampling and testing (211.110)?

• Control procedures must ensure:

  • Adequate mixing for uniformity.

  • Testing of dissolution, pH, and clarity.

  • Compliance with in-process specifications.

• Rejected materials must be identified and controlled.

What does Section 211.113 focus on in terms of microbiological contamination?

• Written procedures must prevent:

  • Microorganisms in non-sterile products.

  • Contamination in sterile products.

• Objectionable microorganisms must be tested and controlled.

What does Section 211.115 specify about reprocessing?

Reprocessing of non-conforming batches must:

• Be reviewed and approved by the quality control unit.

• Not proceed without such approval.

How are obsolete or outdated materials handled (211.122)?

• Obsolete materials (e.g., labels, labeling) must be destroyed.

• Gang printed labeling is prohibited unless adequately differentiated.

What does Section 211.125 specify about labeling issuance?

• Strict control is required with written procedures.

• Labeling materials must be:

  • Carefully examined.

  • Quantities reconciled (issued, used, and returned).

  • Excess labels destroyed.

What are the rules for label use under 211.125?

• Labels must be:

  • Clear and legible.

  • Placed only on the container or equipment body, not on lids.

• Old labels must be removed to avoid confusion.

What are the tamper-evident packaging requirements (211.132)

Over-the-counter (OTC) drug

Packaging must have indicators or barriers

What is required for drug product inspection during finishing operations (211.134)?

• Packaged and labeled products must be visually examined.

• Representative samples must be inspected for correct labeling.

• Inspection records must be documented in the batch production or control records.

What does Section 211.137 specify about expiration dating?