Manufacturing Protocol CONFIDENTIAL

Product Name
Code: Edition: Validity Date:
Código de Producto: Edition No: Version: Effective from: FMF edition No: Sheet 1 of 6
Amount (mL or g): Cantidad (Unidades): Batch Number: N° de Laboratorio: Developed by:
Manufacturing Date: Expiration Date: Name/Signature/Date:

Concentration by Unit
Issuance of Documentation
Assets: Quantities
Carried out: He/She verified:
Documentation Assistant Documentation Coordinator
(Company / Date) Pharmaceutical (Signature / Date)

Reception of the documentation by:

Supervisor / Production Assistant
(Company / Date)

Review of post-manufacturing documentation:

The final documentation contains leaves and

Made:
Supervisor / Production Assistant
(Company / Date)

Final Opinion
Deviations from the process Proceed with the release of this batch.

Production Supervisor Inspection and Audit

YES NO (Company / Date)
YES NO (Company / Date)

Observations: Observations:

Batch: Sheet 1 of 7
Stage of the Process: Raw Materials Heavy Inicio(Firma / Fecha / Hora):

Material: Recommendations / Precautions

Use the necessary clothing (coat and hat) required to minimize the risks of contamination
and required PPE (gloves, mask, and goggles).
Before starting the weighings on the analytical balance, check that the air bubble of the level is in
the center.
Equipment: Before starting the weighings on the Granataria Scale, ensure that the balance beam is at zero.
In the case of adjusting the purity of active ingredients, the calculations must be recorded in the present.
protocol.

Workers (signature/date):_____________________________________________________________

Previous Product: ______________________________________ The area to be used is clean: YES NO

Lot number: ______________________________________
The equipment to be used is clean: YES NO
Authorization of the process: __________________________________
(Company / Date / Time) NOTE: If the previous product corresponds to the same product, cancel these spaces.

Before starting the shift, record the humidity and temperature data of the area. HUMIDITY % TEMPERATURE °C

Heavy Raw Materials Part A

Quantity Quantity Batch number
No. Raw Material Name Executed Controlled Date Checked Date
Theoretical Practice used

Total
Batch: Page 2 of 7
Opinion: Weights were carried out according to the Formula: YES NO Deviation was generated: YES NO
Observations:

Head of Central Weight (Signature / Date) Jefe de Fabricación (Firma / Fecha)

(Weights correspond to formula) The reception of raw materials is in accordance.

Batch: Page 3 of 7
Stage of the Process: Product Manufacturing Inicio(Firma / Fecha / Hora):

Material:
Recommendations / Precautions:
Use the necessary clothing (apron and hat) required to minimize contamination risks.
EPP required (gloves, mask, and goggles).
Team: Label and identify the processes that are carried out
Allocate a container for disposing of the labels
Do not dispose of labels or waste in the drain.
Designate a container for disposing of chemical products to avoid pouring them down the drain.

Workers (signature/date):_____________________________________________________________

Previous Product: ______________________________________ The area to be used is clean. YES NO

Batch number: ______________________________________
Equipment / crystal lighting to be used is located
YES NO
Process authorization: __________________________________ clean
(Company / Date / Time)
NOTE: If the previous product corresponds to the same product, cancel these spaces.

Before starting the process, record the humidity and temperature data of the area. HUMIDITY % TEMPERATURE °C

No. Description Valor Esperado Practical Value Carried out He/She controlled Date

Batch: Sheet 4 of 7
Stage of the Process: Controls in process Final(Firma / Fecha / Hora):

Parameter Expected Value Practical Value Company / Inspection Date Parameter Expected Value Practical Value Company / Inspection Date
Properties Properties
Organoleptic Organoleptic

Viscosity Viscosity

pH pH

Parameter Expected Value Practical Value Company / Inspection Date Parameter Expected Value Practical Value Company / Inspection Date
Properties Properties
Organoleptic Organoleptic

Viscosity Viscosity

pH pH

Opinion: Manufacturing was carried out according to the defined process: IF NO Deviation was generated: YES NO
Observations:

Manufacturing process has concluded:

Manufacturing Manager (Signature / Date / Time)

Batch: Page 5 of 7
Stage of the Process: Summary of Manufacturing
Final Performance Expected Value Practical Value He/She carried outHe/She/It controlledDate
Pharmaceutical Performance

Pharmaceutical Yield Percentage (practical yield over theoretical yield x

%
100)

Documentation attached to this Manufacturing Protocol:

ANNEX DESCRIPTION NUMBER OF PAGES SIGNATURE DATE

Observations

Batch: Page 6 of 7
Batch: Sheet 7 of 7