Micro-dose Dilution Technique, Purpose:
Micro-dose Dilution Technique, To ensure the confirmation of content uniformity of the lower quantity of Active Pharmaceuticals Ingredient (lower than 10 mg per unit) presents in the selective products of the XX pharmaceuticals Limited.
Micro-dose Dilution Technique, Scope:
This SOP is applicable for the selective products (API content less tha10 mg per unit) processes at the
Production Unit of the XX Pharmaceuticals Limited.
Definitions / Abbreviation:
[][]Micro-Dose: Smaller quantity with respect to the Processing Batch Size.
[][]BMR: Batch Manufacturing Record.
Responsibilities:
[][]The Roles and Responsibilities are as follows:
Machine Operator
[][]To follow the laid down procedure.
Executive, Product Development
[][]To establish the steps of dilution as parts of total mixing
Executive, Production
[][]To monitor the steps of dilution as parts with described timeline throughout the Mixing Process.
Manager, Production
[][]To implement this correctly.
Manager, Quality Assurance
[][]To approve the Document.
Annexure:
N/A.
Procedures:
Precautions:
[][]To check all the Materials for the involved batch must be available at the beginning of the process.
[][]First sort out the Active Pharmaceutical Ingredient (API) and excipients from the supplied batch materials.
[][]Divide the API(s) to make them three parts.
[][]First step
[][]Take one third of API (1st part of API) and equal quantity of excipients in a poly bag.
[][]Mix them for 3-5 minutes.(premix-1)
[][]Take premix-1 and equal quantity of excipients (Filler) in the poly bag.
[][]Mix them for 3-5 minutes. (premix-2)
[][]Take premix-2 and equal quantity of excipients (Filler) in the poly bag.
[][]Mix them for 3-5 minutes. (premix-3)
[][]Second Step: Repeat the same process for the second part of API
[][]Third Step: Repeat the same process for the third part of API
[][]Mix first, second and third part of premix respectively for 2-3 minutes clockwise manually.
[][]Calculate the active premix from step into two part A & B.
[][]Take the remaining excipients of batch quantity and pass through Vibratory Sifter or manually sieve.
[][]Then take part A of active premix into Vibratory Sifter.
[][]Take the remaining excipients of 2nd part & pass through Vibratory Sifter or manually sieve.
[][]Then take part B and pass through the Vibratory Sifter or manually sieve.
[][]Now take all the parts to the Cone Blender.
[][]Seal the Cone Blender with its upper part & start dry mixing all the parts as a whole for up to 30 minutes.
[][]Stop the Cone Blender and allow the In-Process Quality Compliance (IPQC) Person to take the required quantity of sample for checking the content uniformity of the Micro-Dose API as of the calculation basis.
[][]If the IPQC person declares the dry mixing status satisfactory, then start the next process as mentioned in the BMR.
[][]If the dry mixing status found unsatisfactory, then go for Cone Blender operation for another 15 minutes. Then follow as mentioned above satisfactory for the next process.
[][]Proceed for next operation as per the BMR.