Standard Operating procedure for Process Change Control

 1          SCOPE:-

This procedure is to be followed while controlling process change in Plant.

2.         OBJECTIVE:-

2.1      To control process variability

2.2      To operate the process smoothly.

3.         RESPONSIBILITY:-

3.1        Plant Manager

3.2        Quality Control Manager

3.3        Quality Assurance Manager

3.4         Inventory Control Manager

3.5         Production Manager

3.6         Maintenance Incharge

4          Critical Process:

4.1       Following are the critical processes in which change need control in order to control Process variability & for smooth operation:

                        4.1.1    Change of source / supplier for starting & Packing Materials

                        4.1.2    Change in standard Batch Size.

                        4.1.3    Change in Product Master Formula.

                        4.1.4    Abrupt change in running manufacturing / packing process.

                        4.1.5    Batch break up during packing. / delay of packing of particular batch for

                                    More than 1 month.

                        4.1.6    Any change in Engineering Process.

                        4.1.7    Change in measuring & / or monitoring frequency.

                        4.1.8    Any other change in Production process.

5          PROCEDURE:-

5.1       Change of source / Supplier of starting & packing material:

5.1.1    For manufacturing of Injectable different type of starting martial actives like APIs & Excipients etc, and different packaging components like Glass  Vials, Glass Ampoules rubber stoppers, seals, labels, cartons etc are used and they are all purchased by different suppliers. The list of approved supplier is available at supply chain Department. If the supplier is to be changed following procedure will be followed.

Inventory Control Manager will intimate the Quality Control Manager and Quality Assurance Manager about supplier change on relevant Form. The approval will be taken about supplier change from Plant Manager on that form.

N.B.

  If the Product / process have been validated for the said supplier (Applied only in case of active pharmaceutical ingredient) the said product / process will be validated prior to commercial use of such material.

5.2       Change in Standard Batch Size:

5.2.1    The standard batch size of each product are mentioned on product master

Formula document of each product. If a change is required in standard

Batch size the following procedure will be followed:

The competent authority (Plant Manager) is only authorize to

Change the standard batch size. If the Batch size is changed to less than the standard batch size, the proposing person will intimate for said change to Quality Control Manager & Quality Assurance Manager for the said change on relevant form. The said change will be implemented after approval from Plant Manager

If the change in batch size is higher than the standard batch size, the said change will be implemented after process validation of said product & approval from Plant Manager on relevant form.

5.3  Change in Product Master Formula:

5.3.1    If the product master formula of any product is to be changed due to any reason the change will be implemented after validation of that particular product / process & stability studies. The formal approval will be guaranteed from Plant Manager

5.4    Abrupt change in running manufacturing / packing process:

5.4.1    If any abrupt change is required in manufacturing / packing process the proposed change will be intimated to Quality Control Manager & Quality Assurance manager on relevant form. The said change will be implemented after approval of Plant Manager on relevant form.

5.5       Batch Break up during packing / Delay in packing of product:

5.5.1    If a break up (mean partial packing) in particular batch is required the said change will be intimated to the Quality Control & Quality Assurance Manager by the person who has proposed the said change on relevant form.

 The change is implemented after approval of Plant Manager on relevant form.

5.6       Any change in Engineering Process:

5.6.1    If a necessary change in engineering process is required the maintenance Incharge will intimate the proposed change to Plant manager on relevant form. The Plant manager will discuss the said change in meeting of Validation committee. The said change will be implemented after approval of chairman of validation committee on relevant form

5.7       Change in monitoring & / or measuring frequency:

            5.7.1    If a change is proposed in measuring and / or monitoring frequency

( like calibration of gauges, environmental monitoring etc) the propose will intimate about the change on relevant form to the Quality Assurance & Quality Control Manager & the change will be implemented after approval of Plant Manager  on relevant form.

5.8              Any other change in Production Process:

If a change is required in manufacturing and / or packing process which is against the approved SMP, the Incharge Pharmacist will intimate the change to production manager. The said change will be communicated to Quality Assurance & Quality Control on relevant form by Production Manager. QA & QC Manager review the change and feel it minor they will recommend the change otherwise it will be implemented after Validation. The change will be implemented after approval of Plant Manager on relevant form.

5.9              Any other change in Quality Control Testing Procedures:

If a change is required in QC testing procedure which is against the approved SAP, the QC Analyst will intimate the change to QC manager. The said change will be communicated to Quality Assurance on relevant form by QC Manager. QA Manager review the change and feel it minor he will recommend the change otherwise it will be implemented after Validation. The proposed change will be implemented after approval of Plant Manager on relevant form