Key Notes on Revised Schedule M: Point No. 18 – Good practices in production

Key considerations for Point No. 18 –Good practices in production for compliance under revised Schedule M are outlined below in the article.

December 30, 2024

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SDCO Cum Licensing Authority |
Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com

Good practices in production

Key considerations for Point No. 18 –Good practices in production for compliance under revised Schedule M are outlined below.

All production operations must strictly follow written procedures and instructions aligned with manufacturing licenses.

All handling steps, including receipt, cleaning, quarantine, sampling, storage, labeling, dispensing, processing, packaging, and distribution, must be documented.
Deviations from procedures should be minimized and, if necessary, authorized in writing with QC involvement.
Yield checks and quantity reconciliations should be performed to ensure accuracy.
Simultaneous or consecutive processing of different products in the same area must be avoided to prevent mix-ups and cross-contamination.
Materials, bulk containers, equipment, and rooms must be clearly labeled with product, strength, batch number, and stage of production information.
Access to production areas should be restricted to authorized personnel.
Non-medicinal products must not be produced in areas or with equipment designated for pharmaceutical products.
In-process controls should be conducted without compromising product quality or causing cross-contamination.

Dust control measures should be implemented for dry materials and products.
Contamination risks from dust, gases, particles, vapors, sprays, organisms, residues, insects, and personnel should be minimized.
Cross-contamination prevention strategies include:
Dedicated production areas for sensitive products
Campaign production with validated cleaning procedures
Airlocks, pressure differentials, and air filtration systems
Minimizing recirculated or untreated air

Protective clothing
Effective cleaning and decontamination procedures
Closed system production
Residue testing
Cleanliness status labels on equipment
Periodic monitoring of production areas for microbiological and particulate contamination should be conducted.

Before starting a processing operation, the work area and equipment must be cleaned and free from extraneous materials.
In-process and environmental controls should be carried out and recorded.
Equipment failures should be promptly addressed and defective equipment removed from use.
Cleaning and storage procedures for production equipment must be followed.
Time limits for storing process materials and equipment should be defined and adhered to.
Containers for filling must be cleaned to remove contaminants.

Significant yield deviations should be investigated and documented.
Pipeline and equipment connections should be verified.
Water pipes should be sanitized and stored according to written procedures.
Measuring, weighing, recording, and control equipment must be calibrated and checked regularly.
Repair and maintenance operations should not compromise product quality.

Packaging operations should be planned to minimize cross-contamination, mix-ups, and substitutions.
Before packaging, the work area, packaging lines, and equipment must be cleaned and cleared of previous materials.
Product name and batch number should be displayed at each packaging station.
Filling, sealing, and labeling should be timely to prevent mix-ups and mislabeling.
Printing accuracy should be checked and recorded.
Special care should be taken for cut labels, offline overprinting, and hand-packaging operations.
Printed information on packaging materials should be clear and durable.

Online controls during packaging should include checks on package appearance, completeness, correct product and material usage, overprinting accuracy, and line monitor function.
Samples taken from the packaging line should not be returned.
Products involved in unusual packaging events should only be reintroduced after inspection, investigation, and approval.
Significant discrepancies in bulk product, packaging materials, and unit production should be investigated and documented.
Unused batch-coded packaging materials should be destroyed, and a procedure should be followed for returning uncoded materials to stock.
Production records should be reviewed and any deviations or failures investigated.

Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana