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5.0 Production

Before commencing manufacturing operation, the supervisor will ensure that the manufacturing area and the equipment to be used for manufacturing are clean and labeled. Line clearance is obtained from QA.
The steps involved in manufacturing are clearly defined in batch manufacturing record for individual products. All the steps will be carried out as indicated in BMR.
The weights of the raw materials are cross checked before commencement of manufacturing operation.
The equipments are operated as per Standard operating procedures.
After completion of manufacturing operation sampling of bulk is done by Quality Control Department after receiving Test request form from Production department.
After getting approval for filling from the Quality Control, Filling and packing is started as per batch packing record
At frequent intervals fill volume / weight, sealing, batch coding, etc are checked and the same is recorded in Batch packing record
Finished product sampling will be done by QA and the same is analyzed as per the written procedure.
The steps involved in manufacturing semisolids / liquids are briefly summarized in the form of flow chart given as ANNEXURE – X [ A,B,C,D ]

Reprocessing & reworking will be considered if there is a need & technically justified.

On receipt of the material stores personnel will check and conform the integrity of the containers and packages. Suspect containers and packages will be segregated for an exhaustive examination by QA / QC personnel.
To prevent entry of contaminants picked up in transit, all containers, packages etc are effectively cleaned before these are admitted to the storage area.
“Material received” label is put on the containers Goods received Note is made and sent to QC department for sampling and further analysis.
After sampling, QC department puts “Under Test label”. After analysis “Approved”/ “Rejected” label is put. Format for all these labels are made and details are written by hand and duly signed by concerned person.
Sampling of raw materials and Packing materials is done as per the written procedure.
Sampling booth is used for sampling of raw materials.
Materials are segregated as active and inactive.
Each and every container of active ingredients is sampled. Inactive ingredients are sampled using the formulae square root of (n + 1), where n = no. of containers.
After getting approval from QC department, both raw and packing materials are dispensed.
On receiving work order from QA department and after checking of work order from Production Department, dispensing activity is undertaken.
Dispensing raw materials is done in the dispensing booth and separately designated liquid dispensing area as required on the basis of first in first out, first expiry.
Packing materials are dispensed in packing material dispensing area. .Separate area is specified for decartoning of materials. Materials are dispensed as per the work order. After dispensing, materials are kept in a staging room and informed to Production department.
All dispensed materials are cross checked for their gross weight/qty and with dispensing slip and work order by production supervisors before use.
There are 3 different areas, Yellow area for under test, Green area for approved materials and Red area for rejected materials. The areas are differentiated by respective color bands on floor and in some areas respective colored ropes are used. Materials are segregated based on their status and are placed on the racks/pallets.
Labels and cartons (preprinted materials) are kept in the rack under lock and key.
Entry to stores is restricted only to authorized persons.

Materials and products that are labeled as Rejected are kept separately in red racks meant for rejection.
These racks are under lock and key and are under control of QA.
The rejected materials are sent back to the manufacturer or supplier, along with one copy of analytical report with appropriate reasons for rejection, or are destroyed based on the decision of QA/QC Manager.
Rejected packing materials returned from the Production department are collected separately and are destroyed as per the written procedures and the same is recorded
Products not complying with the specifications are quarantined at that stage of manufacture.
Reason for non-conformance is investigated and a decision either to reprocess in accordance with an authorized instruction or to destroy is taken by Quality Assurance and the same is recorded.

Three batches of all the products initially manufactured, of same batch size are being validated and kept for stability studies as per ICH guidelines and all the validation processes are documented.
All the processes validated are recorded in the Process Validation protocols.
If any active or inactive ingredients & any equipment are changed, even then the process validation will be done as per written procedures and protocols.
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