1.0 Purpose
1.1 To define the procedure to control the manufacturing flow for storage Intermediate and Bulk Products and its regulation in compliance with product quality.
2.0
Scope
2.1 This Sop is applicable for all Intermediate
and Bulk of "NAME" Pharmaceuticals Ltd.
3.0
Responsibility
3.1
Only concern Operator and
Supervisor is responsible to follow the procedure correctly.. He/ She inform
the supervisor about any deviation from normal operation. He also maintains log
book.
3.2
Sr. Officer-
Production/Officer- Production is responsible for monitoring day to day
activity.
3.3 Production Officer and Quality
Assurance Officer should ensure that the procedure is implemented properly.
4.0 Abbreviations and Definitions
4.1 BMR :Batch Manufacturing Record
4.2 Intermediate : A partly processed material that must undergo the further manufacturing steps before a bulk product.
4.3 Bulk Product : Any product that has completed all processing steps up to but not including final packaging.
5.0 Materials and Equipment
5.1 Clean empty drum
5.2 Poly bag
5.3 Cable tie
6.0 Precaution / Health and Safety Considerations
6.1 Personal engaged in handling of filled drum carefully to avoid an accident.
6.2 Filled drum must be keep over the pallet.
6.3 Each batch containing more the one drum must be tightened with the piece of plastic rope.
6.4 Each drum must be cleaned and properly labeled inside and outside.
6.5 Lid of each drum must be closed.
6.6 Electrical balance must be carefully used.
6.7 Relative humidity and temperature record must be updated every day.
7.0 Procedure
7.1 Granulation
7.1.1 After completion of granulation, granules filled into clean empty drum with double lined poly bag. Tightened the poly bag by cable tie/rubber band.
7.1.2 Affix the “Product Status Label” mentioning product name, batch number, batch size, number of container and keep the filled drum into the WIP room after weighing and give entry into the WIP register (Annexure-II) and store until further Process. (Compression, Encapsulation, Bottle Filling)
7.2 Compression
7.2.1 Take the granules from WIP and get the signature into the WIP register (Annexure-II).
7.2.2 Collect the tablets into empty drum with double lined poly bag Drum labeled with product name, batch number, gross weight, tare weight, net weight and number of container.
7.2.3 After completion of compression, store properly labeled drum in WIP after weighing and give entry into WIP register and store until required for process.
7.2.4 Uncoated tablet store in WIP for packaging and give entry into the product transfer register.
7.3 Coating
7.3.1 Collect core tablet with properly labeled and correct compressed tablet in accordance with BMR from WIP and get signature into the WIP register(Annexure-II).
7.3.2 After completion of coating, coated tablet filled into drum with double lined poly bag. Tightened the poly bag and keep the drum into the WIP room after weighing.
7.3.3 Affix the “Product Status Label” mentioning product name, batch number, batch size, number of container and keep the filled drum into the WIP room after weighing and give entry into the WIP register.
7.3.4 Coated Tablet transfer to WIP of packaging section by entry into the product transfer register.
7.4 Encapsulation
7.4.1 Take the granules from WIP and get signature into the WIP register (Annexure-II).
7.4.2 Collect the capsule into empty drum with double lined poly bag. Drum labeled with product name, batch number, gross weight, tare weight, net weight and number of container.
7.4.3 After completion of encapsulation, store properly labeled drum in WIP after weighing and give entry into WIP register and store until required for process.
7.4.4 Capsules store in WIP for packaging and give entry into the product transfer register.
7.5 Blister Strip
7.5.1 When Inner carton or case cover are short to complete the packaging, then the blister strip are keep into the drum / master carton and close the mouth and entry into the WIP register and store until further packing.
7.5.2 Affix the “Product Status Label” mentioning product name, batch number, batch size, number of container.
7.5.3 Blister strips are transfer to packaging section by entry into the register.
7.6 Tablet Counting / Filled Bottle
7.6.1 When label or Inner carton are short to complete the packaging, then the filled bottle are keep into the master carton / drum and close the mouth and entry into the WIP register and store until further packing.
7.6.2 After completion of bottle filling, give entry into the product transfer register for packaging.
7.7 Temperature and Humidity Record:
7.7.1 Note down the temperature and humidity twice in a day in “Temperature & Relative Humidity Monitoring Records” logbook.
7.7.2 The specific time for noting temperature and humidity shall be 8.00 am to 10.00 am and 12.30 pm to 2.30 pm.
8.0
Reference
Document
8.1 In-house
9.0 Annexure
9.1 Annexure-I : Temperature & Relative Humidity Monitoring Records
9.2 Annexure-II : Format of “WIP Log book”
10.0
Revision
History
|
Revision No. |
Brief
reason for the revision |
Effective Date |
Remarks |
|
01 |
New |
|
|
11.0 Training
11.1 Head of Production or his nominee give the training of production operator and worker.
