The Limits Of Yield in Pharmaceuticals SOP

Standard Operating Procedure of The Limits Of Yield in Pharmaceuticals SOP 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 controlled & improved.

4. MATERIAL & EQUIPMENT

Related to batch production and documented record.

5. PROCEDURE

5.1 Production officers are responsible 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 (Human Section)

I. Tablets (Coated & Uncoated):

PROCESS	Expected Loss (%)	Expected Yield (%)
Blending	0.5%	99.5% - 100%
Compression	1.5%	98% - 99.5%
Coating	0.5%	97.5% - 98%
Packing	2.5%	95% - 97.5%

II. Capsules

PROCESS	Expected Loss (%)	Expected Yield (%)
Pellets Filling Only	1%	99% - 100%
Blending	0.5%	99.5% - 100%
Powder Filling	0.5%	99% - 99.5%
Packing	2.5%	96.5%-99%

III. Oral Liquids:

PROCESS	Expected Loss (%)	Expected Yield (%)
Solution Preparation	0.5%	99.5% - 100%
Filling & Sealing	0.5%	99% - 99.5%
Packing	2%	97% - 99%

IV. Liquid Injectable (Ampoule)

PROCESS	Expected Loss (%)	Expected Yield (%)
Solution Preparation, Filtration, Filling & Sealing	2%	98% - 100%
Autoclave & Optical Inspection	5%	93% - 98%
Labelling & Packing	1%	92% - 93%

Veternary Section

I. BOLUS

PROCESS	Expected Loss (%)	Expected Yield (%)
Blending	1%	99% - 100%
Compression	1.5%	97.5% - 99%
Packing	2.5%	95% - 97.5%

II. POWDER

PROCESS	Expected Loss (%)	Expected Yield (%)
Blending	0.5%	99.5% - 100%
Packaging	1.5%	98% - 99.5%

III Oral Liquid Drench:

PROCESS	Expected Loss (%)	Expected Yield (%)
Solution Preparation	0.5%	99.5% - 100%
Filling & Sealing	0.5%	99% - 99.5%
Labelling & Packing	2%	97% - 99%

IV. Liquid Injectable (Vials):

PROCESS	Expected Loss (%)	Expected Yield (%)
Solution Preparation, Filtration, Filling & Sealing	1%	99% - 100%
Optical Inspection	3%	96% - 99%
Labelling & Packing	1%	95% - 96%