SOP for manufacturing of Placebo or Dummy batches

1.0 OBJECTIVE: 

To describe the procedure for manufacturing of Placebo or Dummy batches.

2.0 SCOPE:

This SOP covers the procedure for manufacturing of Placebo or Dummy batches in manufacturing area at [company name].

3.0 RESPONSIBILITY:

Head production: manufacturing of Placebo or Dummy.

Head QA: To ensure the compliance.     

4.0 PROCEDURE:

4.1 For preparation of Placebo or Dummy batches, Batch Manufacturing Record (BMR) shall be prepared.

4.2 Formula for manufacturing of the Placebo or Dummy batches shall be set based on product formulation. 

4.3 Quantity of the active pharmaceutical ingredient shall be supplemented with the equivalent quantity of diluents while formulating placebo batch. The diluent selected in place of active ingredient will be that diluent whose quantity is more in the formula. 

4.4 The production person will initiate the requisition of material prior to manufacturing of the Placebo or Dummy batches preparation of Batch Manufacturing Record (BMR).

4.5 The Documentation person shall issue the BMR as per procedure mention in the respective SOP. The batch numbering system for Placebo or Dummy batches will be as per respective SOP.

4.6 The production person will start the manufacturing of the Placebo or Dummy batches as per the BMR. The BMR shall have all the manufacturing steps as per product manufacturing process.

4.7 Manufacturing process covers granulation, compression, Coating, Capsule filling, etc. For liquid formulations, solution preparation, filtration, and other steps, shall be done as per the requirements in the respective area and manufacturing operation may be targeted accordingly.

4.8 Sampling shall be performed need base and testing shall be performed if required.

4.9 Manufacturing of the Placebo or Dummy batches shall be done in following cases but not limited to:

(i) Product requirement; 

(ii) Machine trial;

(iii) Change part trial; 

(iv) Analytical testing

Requirement of Placebo or Dummy batch manufacturing shall be approved from quality assurance department. Any suitable formulation shall be taken for Machine/ Change part trail based logical reason and scientific sound rationale.

4.10 Placebo or dummy batches shall be subjected to destruction as per the relevant procedure.

4.11 The duly completed BMR shall be returned to QA for verification and archive the same. 

5.0 ANNEXURE:

No Annexure