PRODUCTION AND PROCESS CONTROL -SOP

1.0 PURPOSE :

This procedure ensures that all activities necessary for the manufacture and packaging of our products are planned and controlled to ensure that at all stages the product conforms to the specified requirements.

2.0 SCOPE :

This procedure applies to all manufacturing and packing operations starting from production planning, issue of works order (Batch Manufacturing Record) to completion of packing operations.

3.0 RESPONSIBILITY :

General Manager-Quality Assurance

4.0 ACCOUNTABILITY:

President - Technical

5.0 DEFINITIONS :

5.1 Bulk product :

Any product that has completed all processing stages up to, but not including, packaging.

5.2 In-process control :

Checks performed during production to monitor and if necessary to adjust the process to ensure that the product conforms to its specifications. The control of the environment or equipment may also be regarded as a part of in-process control.



5.3 Manufacture :

All operations involving conversion of raw materials to bulk product and the related controls.

5.4 Packaging :

All operations including filling and labeling, that a bulk product has to undergo in order to become a finished product.

5.5 Release Specification :

A document describing in detail in-house requirements (which have requirements Additional to statutory requirements and limits of certain quality parameters, which are more stringent than the statutory limits) with which the intermediate product and finished product must comply.

5.6 Stage Verification :

Checks performed in the course of manufacture on intermediate product before it is released for processing to next stage, to ensure that it conforms to its specifications.

5.7 Standard Monthly Requirement:
Estimated monthly off take of the standard products based on the historical data and projected sales forecast for the product. This requirement is drawn by the President – Technical in consultation with the Managing Director.

5.8 BMR : Batch Manufacturing Record

5.9 MFR : Master Formula Record

5.10 GMP : Good Manufacturing Practice



6.0 PROCEDURE :

6.1 Production Planning :

6.1.1 The Marketing Department shall prepare a sales plan and send it to the President – Technical .

6.1.2 The President –Technical shall arrange to send necessary indents for fulfilling the planned production. A copy of the plan shall be sent to the stores Manager and Production Manager.

6.1.3 The Stores Manager shall raise indents for all the materials required for meeting the production plan. Additionally, he shall raise indents for materials required for processing non-standard orders. (Refer to QAP:0301, Contract Review).

6.1.4 The Purchase Manager shall arrange to procure all materials required
for fulfilling the production plan and non-standard orders based on the indents raised by the Stores Manager.

6.1.5 The Production Manager shall prepare Weekly Production Schedule F:0801/WPS for bulk manufacturing and packaging F:0801/PSE on the basis of production plan sent by marketing giving priority to low stock items as revealed in the Weekly Review Sheet F:0801/WRS of standard products having stock less than standard monthly requirement. Priority shall also be given for non-standard orders in
Relation to the delivery dates. Copies of the Weekly Schedule shall be sent to the Packaging Manager and to P.M the Stores.

6.1.6 For the execution of the weekly schedule, the Production Manager shall ensure that the required equipment, manpower and the Master Formula Records (MFR) are available.


5.2 Production Process:

5.2.1 The Production Manager shall initiate the production process by issuing for every batch of a product an authorized Batch Manufacturing Record (BMR) taking care to include in the batch size any utilizable residues from previous batches. The Batch Manufacturing Record shall have the reference no. of the current issue of the Master Formula Record. The procedure for Creation and Completion of BMR is detailed in QAP:0802.The Master Formula Record consists of details of work instructions to be carried out. It shall be prepared by the R&D officer in consultation with the Plant Manager, approved by the Senior Quality Assurance Manager and authorized by the President –Technical. The Master Formula Record of a product provides the following information :

a. Label claim, Overages, Input per unit dosage form, Life Period, Unit Pack and a reference to the Product and Product Pack Specifications,
b. Batch formula for the standard batch size,
c. List of equipment required,
d. Manufacturing method providing details of stepwise processing, including check for the cleanliness of the equipment, verification of materials, pre-treatment of materials, sequence of adding the materials,

e. Special precautions if any, control of temperature and humidity (as relevant).
f. Instructions for stage verification and in-process checks.
g. List of packing materials required and the Master Packaging Instructions.

5.2.2 Responsibility: Head of the Department (Bulk Product Manufacturing)

5.2.2.1 The production process shall be initiated by obtaining input materials in advance of the production schedule.

5.2.2.2 The production shall be carried out strictly in accordance with the instructions given in the MFR, the instructions covering GMP as detailed in QAP:0803, the In-Process checks as detailed in QAP:0902 and the main steps involved in this procedure are as under :
a. Pre-production checks,
b. Initial checks,
c. Machine setting checks, Processing of the batch (Manufacturing operation) including stage verifications.
d. In-process checks,
e. Clean-up of the area and the equipment at the end of the day and at the end of the batch.

5.2.2.3 Any deviation from the MFR, regarding any aspect-batch size, the formulation, equipment to be used, the method of manufacture - shall be Authorized by the Senior Quality Assurance Manager and the President –Technical. Authorization form for deviation (F:0801/AFD/A) shall be used for this purpose. Reasons for and the details of deviation shall be recorded on this form and thereafter the
manufacture shall proceed according to the Authorized deviation. If the deviation is of a nature which requires consequential change in document and/or stability study, the F:0801/AFD/A shall be numbered as AFD-01,02 etc. and entered in a Authorization for Deviation Register (F:0801/ADR). The Senior. Q. A. Manager shall be responsible for monitoring and completion of such corrective actions

5.2.2.4 Pre-production Checks :

i. Verifications of all materials shall be done to confirm that the materials received are the materials indented and only materials which are approved by Quality Control are issued for manufacturing.
ii. Machine changecove
All machinery and equipment required for the batch shall be kept clean and In ready-for-use condition.
iii. Line clearance :
The area required for manufacture shall be free from the materials and records of the previous batch.
iv. Area set-up :
Items, apart from machinery and equipment, such as pallets, containers for Handling storage and sampling of products, containers for placing gloves and Nose masks, vacuum cleaners etc. shall be provided in each area.

5.2.2.5 Initial Checks :

These checks shall be performed every morning and before manufacture of a Fresh batch commences to confirm that the environmental conditions such as Temperature, humidity are satisfactory, operators are properly covered and Trained operators are allocated for carrying out the various jobs.
5.2.2.6 Machine setting Checks :

These checks shall be performed to ensure that the quality parameters of the product obtained during the machine setting are within acceptable limits which shall be certified by the Quality Assurance Manager since these checks are critical. (Refer to QAP:0902, In-process inspection and testing)

5.2.2.7 Processing of the batch :

After completion of the above checks processing of the batch shall be carried out. Stage verifications described in individual MFRs and those related to release specifications shall be performed to confirm compliance with the requirements before the bulk is released for the next stage of manufacture. If the bulk fails to meet the release specification the batch shall be re-processed according to QAP:1201, Control of Nonconforming Product. The
recoverable residue arising out of the processing stages shall be collected and handled according to QAP:1202, Handling of Product Residue.

5.2.2.8 In-process Checks :

In the course of manufacture, necessary in-process checks detailed in Annexure to QAP:0902, shall be performed to ensure that the product Continues to remain within the acceptable limits during the entire process of Manufacturing.
5.2.2.9 At every stage of manufacture the yield shall be calculated and entered on the BMR.

5.2.3 Responsibility: The Packaging Manager

5.2.3.1 Packing of the bulk product shall be initiated by obtaining Quality Control approved product and packing materials in advance.

5.2.3.2 Packing of the bulk product shall be carried out strictly in accordance with the instructions given in the Master Packaging Instructions,
Instructions covering in GMP as detailed in the QAP:0904 Packing of Bulk Product and In-Process Checks as detailed in QAP:0902.

The main steps involved in this procedure are as under :

a. Pre-packing checks,
b. Initial checks,
c. Machine setting checks,
d. Packing of the batch
e. In-process checks,
f. Procedure for planned partial packing.
g. Interruption of packing operation,
h. Closing of the packing operation at the end of the day.
i. Completion of the batch.

5.2.3.3 Pre-packing Checks : Step 5.2.2.4 shall be followed.

5.2.3.4 Initial Checks : Step 5.2.2.5 shall be followed.

5.2.3.5 Machine Setting Checks : Step 5.2.2.6 shall be followed.

5.2.3.6 Packing of the batch :

The overprinting of printed packing materials shall be organized well in advance so as to make overprinted and checked packing material available for packing as per the Packing Schedule. Availability of stereo mats for foil printing shall also be confirmed in advance. The overprinted material shall be examined by the Quality Assurance Manager and cleared for use in packing. The packing operation shall be carried out according to Master Packing Instructions given in the MFR.

5.2.3.7 In-process Checks :

In the course of packing, necessary In-process Checks, detailed in QAP:1002,shall be performed to ensure that the product continues to remain within the acceptable limits during the entire process of packing.

5.2.3.8 Procedure for planned partial packing and Interruption of packing operation:

Special precautions with regard to return of unpacked bulk product, unused materials and storage of semi-finished, goods shall be taken to avoid mix-ups, confusion in the event of a batch not being packed completely.




5.2.3.9 Completion of the batch :

After completion of the batch, reconciliation of the product and pack shall be done, rejected materials destroyed and surplus materials returned to the stores. Simultaneously, the BMR shall be completed according to QAP:0902, Creation and Completion of BMR. Residues
Arising at the packing stage shall be handled according to QAP:1302. The BMR shall be submitted to the Quality Assurance Manager for review and approval.


6.0 DOCUMENTATION :

6.1 F:0801/AFD/A - Authorization for deviation in the manufacture of a batch.
6.2 F:0801/WRS - Weekly Review Sheet
6.3 F:0801/WPS - Weekly Production Schedule
6.4 F:0801/PSE - Packing Schedule
6.5 F:0801/ADR - Authorization for Deviation Register