Statistical Process Analysis in Pharmaceuticals

Standard Operating Procedure of Statistical Process Analysis in Pharmaceuticals is describe in this post.

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1. PURPOSE

To establish a procedure for checking and controlling the yields at different stages of batch manufacturing, starting from primary mixing till finished goods packing stage. 

2. SCOPE

This standard operating procedure is applicable to all products, which are manufactured and packed in Pharmaceuticals.

3. RESPONSIBILITY

3.1 Production Pharmacist is responsible to check the yields and minimize wastage during batch manufacturing and packaging.

3.2 QA Officer is responsible for verifying the product yields at different stages and analyzing any deviations which impact yield reduction during processes.

3.3 Production Manager is responsible to improve and sustain yield controls.

3.4 QA Manager is responsible for assuring that yields are verified and analysis is done if necessary.

4. MATERIAL & EQUIPMENT

Related to batch production and documented record.

5. PROCEDURE

5.1 Production officers are to check and ensure that the yields are within limit at the end of  different production process.

5.2 In case of variation in the output justification should be written in batch manufacturing record at reconciliation sheet.

5.3 The limits are following.

I. Tablets (Coated & Uncoated):

PROCESS	Expected Loss (%)	Expected Yield (%)
Pre-mixing	1.0	99 − 100
Blending	1.0	98 − 99
Compression	0.5	97.5 − 98
Packaging (finished)	2.5	97.5    − 95

II. Capsules:

PROCESS	Expected Loss (%)	Expected Yield (%)
Pellets Filling Only
Powder Filling
Blending	1.0	99 − 100
Encapsulation	3.0	96 − 99
Packaging	1.0	96 − 95

III. Oral Liquids

PROCESS	Expected Loss (%)	Expected Yield (%)
Solution Manufacturing	1.0	99 − 100
Filling	3.0	96 − 99
Packing	1.0	96      − 95

IV. Liquid Injectable (Ampoule)

PROCESS	Expected Loss (%)	Expected Yield (%)
Filling	2.0	98 − 100
Optical Inspection	5.0	93 − 98
Packaging	1.0	92 − 93

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