Submission Requirements for Applicants
- Applicants seeking batch certification must submit a formal letter of request.
- Included in the submission are detailed documentation and product samples for evaluation.
Documentation Requirements
- Complete production record of the batch concerned, providing comprehensive details of the manufacturing process.
- In-process control record of the batch concerned, documenting the monitoring of critical parameters during production.
- Complete terminal quality control record, fulfilling all requirements stipulated in the official monograph for the antibiotic batch.
Sample Requirements for Validation
- For suspensions or syrups: six (6) bottles must be submitted.
- For tablets or capsules: one (1) bottle containing 100 units, or two (2) bottles each containing 50 units, or an equivalent number of stripped or blister-packed units.
- For injectable forms: six (6) vials or ampules.
- For ointments or creams: four (4) tubes.
Authority and Compliance
- This memorandum circular was adopted on May 7, 1990, under the authority of the BFAD Director, Cecile P. Gonzalez.
- All concerned parties are required to adhere to these guidelines to ensure compliance with batch certification procedures for antibiotics.