Master Formula & Standard Operating Procedures in Pharmacy

DF.GMP: Good Manufacturing Practices Procedure

Buenas prácticas de elaboración.

PNT: Standardized Written Procedures

Standardized written procedures (PNT) are approved according to proper standards, setting and monitoring the activities performed, both in developing a formulation or Master Formula (FM), and in their quality control.

Types of PNT

• General Procedures: Describe general affairs of several departments.
• Specific Procedures: Describe staff and organizational methods or rules of a department, e.g., cleaning tools.

Label Data (Etiket)

1. RP or FM: The name must match the form set out in the National Formulary.
2. Complete Composition: At least the active pharmaceutical ingredient (API) and excipients.
3. Pharmaceutical Form (FF), Route of Administration, and Dispensing Method.
4. Registration Number: In the prescription book.
5. Batch Number.
6. Preparation Date and Expiration Date: If applicable.
7. Storage Conditions: If applicable.
8. Prescribing Physician's Name and License Number: For prescription preparations.
9. Patient's Name: If the FM requires it.
10. Identification: If applicable.
11. Warning: Keep out of reach of children.

Patient Information Data

1. Patient data.
2. Group to which the patient belongs.
3. Title of the normalized procedure.
4. Procedure code.

Rules Approval

RD 175/2001 of February 23.

DF FM vs. DF RB

• DF FM (Master Formula): A drug developed at a pharmacy, prepared by the pharmacist for a specific individual and requires a prescription.
• DF RB (Ready-to-Use Formula): A drug developed at a pharmacy, prepared by the pharmacist for more than one person (general public), and does not require a prescription in the National Formulary.

Levels of Preparation and Services

1. Label, FF.
2. Preparation of topical, oral, non-sterile, and liquid FF, and sachets (papelillos).
3. Preparation of solid oral, rectal, and vaginal FF.
4. Preparation of sterile FF.

Equipment Sections of NTP

1. Technical description.
2. Location.
3. Parts description of the equipment.
4. Operation.
5. Cleaning.
6. Calibration.

PNT for Processing Formulas

• Preparation ID: Name or detailed formulated composition.
• Necessary Equipment: All equipment numbers for processing.
• Tools Needed: All material points.
• Process Instructions: Detailing the procedure for preparing and labeling.
• Quality Control Tests: Tests necessary to ensure quality.
• Patient Information: Storage conditions and expiry.

Hygiene in the Development of FM and Master Formulas

1. No eating, smoking, or chewing gum, as well as performing unsanitary practices likely to contaminate the area.
2. The need to use lockers for clothing and personal items.
3. Proper clothing depending on the types of preparation.
4. Cleaning and restoration of these clothes regularly.
5. Temporary separation of individuals with diseases, skin lesions, or transmissible diseases from the preparation area.

Premises Requirements

1. The premises are used exclusively for the manufacture of FM and Master Formulas.
2. Appropriate and differentiated areas for weighing, production, and packaging.
3. Wide area to avoid risks.
4. Smooth and easy-to-clean surfaces.
5. Needs depend on the type of preparation.
6. Premises equipped with:
   • Smooth, impermeable, and resistant surfaces.
   • Sink with hot and cold water.
   • Differentiated areas.
   • Scales.
   • Horizontal support for reading and writing.
   • Cabinets, drawers, refrigerator with thermometer.
   • Separate quarantine area.

Minimum Equipment

Precision balance, volume measurement devices, mortars, glass, water bath system, agitator, spatulas, thermometers, glassware, magnifiers, heat production system, system for pH detection.

Types of GMP

Preparation, dispensing, inventory, non-local, personal, premises.

Key Points of Preparation for FM and Master Formulas

Preliminary Findings

Absence of foreign materials, necessary documentation, proper operation, proper cleaning.

Elaboration

Supervision of the pharmacist, correct labeling, proper selection of material, form preparation, quality control, GMP, expiration date.

Key Points of the Tools

1. Be calibrated.
2. Easily removable parts that do not alter the product's quality.
3. Cleanable surfaces.
4. A written program for cleaning and operation.
5. Controlled and calibrated.

Tasks of the Pharmacist

The pharmacist is responsible for the preparations made in the manufacture of any preparation. Only the pharmacist, or under their direct control, can perform the assigned work control operations. The pharmacist is also responsible for organizing the self-inspection and producing standards for staff recycling and personal hygiene.