PHARMA DEVILS

PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Vernacular SOP: No

1.0 OBJECTIVE:
1.1 To lay down the procedure for conducting of manufacturing of trials to be conducted with the facility (in
house) or outside.

2.0 SCOPE”
2.1 The procedure defined in the SOP is applicable only to machine or packing trials or proposed product
trials. This SOP is not applicable for conducting any type of reprocessing on commercial or registration
products.

3.0 RESPONSIBILITY:
3.1 Officer/ Executive: Production: Raising proposal for conducting trials and for conducting trial.
3.2 Officer/ Executive, Stores: For arranging material
3.3 IPQA - Shall ensure compliance of the SOP.
3.4 Head- Production, QA & Store - Shall ensure compliance of the SOP.

4.0 DEFINITION(S):
4.1 NA

5.0 PROCEDURE:
5.1 SOP is applicable for conducting any trial at outside and inside the facility.
5.2 It is applicable for trial of new machine, qualification, new machine change part, change part / artwork
development or Product development, engineering batch or in case both raw material & packaging material
is required to be used or sent to the vendor, the material may be allowed to issue as per the following
procedure.
5.3 Requisition for approval of proposal shall be raised to QA. (Refer Annexure-IV) (Proposal Request for
Trial Batch (Outside).
5.3.1 On issuance, the form shall be filled to provide the following information:
- Purpose of trial/ engineering batch.
- Material (raw and packing) material to be used along with quantity
5.3.2 The request shall be approved by Head, Production and forwarded to QA for review, request shall be raised
by concerned department.
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

5.3.3 Head QA shall assess the Information for taking a decision for approval or rejection of proposal. If
approved, trial shall be undertaken on completion of activities defined in the final assessment.
5.3.4 The form with other department comments shall be returned to QA for review by head, Plant and QA Head.
Once approved, the material shall be sent out to the party (Reference SOP “Movement of material”).
5.4 In the case in in house trial is to be conducted to reason defined in scope, the following procedure shall be
followed.
5.4.1 Production department shall raise a requisition as per Annexure-III “Proposal Request
For Trial Batch” to QA Head for approval. On receipt of the form, the following
Information shall be filled in and approved by Head, Production.
- Proposed plan for Trial
- Equipment Usage Details (include all major equipment to be used)
- Brief description of process to be followed or provide / attach reference procedure to be followed
- Batch Size
- Material Usage details
- Obtained from R&D/ Other Site
- Proposed BOM with quantity, API details, etc.
- Sampling and testing requirement
- The filled and approve request shall be forwarded to QA for impact assessment on, at least the
following:
- Impact on existing license
- Impact on Qualification of equipment/ area
- Impact of Cleaning Procedures of equipment/ area
- Impact on Cleaning Validation/ Verification
5.4.2 Following assessment, the form shall be sent to various department, identified during
the review for evaluation and comments.
5.4.3 On receipt of comments from various departments, Head QA shall assess the
Information for taking a decision for approval or rejection of proposal. If approved, trial shall be undertaken
on completion of activities defined in the final assessment.
To conduct trial, production shall request a batch no. The assigned batch number shall be recorded on
Annexure-II ““Trial Record”, duly signed by QA officer, assigning the batch no.
5.4.5 The trial shall be recorded on Annexure-II “Trial Record”.
The record shall be used for recording the processing of the batch including line Clearance, equipment
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

usage and conclusion of trial.

5.5 On conclusion of trial, the batch shall be destroyed. The destruction of the batch shall be recorded on
Annexure-II.
5.6 The issuance of the raw/ packing materials shall be made by the officer / executive of user department as
per Annexure-I.
5.7 The Head of department or designee shall check and sign the requisition.
5.7.1 The requisition shall be forwarded to the Head Plant and Head QA for final approval.
5.7.2 After approval, issue the material from store.
5.7.3 Printed packing material shall be defaced first then allowed to move out of factory.
5.7.4 Swab verification sample of trial batch shall not be send to Q.C. for analysis.

Note: - In case of the engineering/ trail batch, if batch size is less than one lakh tablet/capsule than trail will be
conducted and reported in Annexure – II (Trial Record) and in case of batch size of trail equal to one lakh or more
than one lakh, current batch record (can be of any market) shall be issued with trail batch record batch number.

6.0 ABBREVIATION(S):
6.1 QA : Quality Assurance.
6.2 SOP : Standard Operating Procedure.
6.3 P&A : Personnel and Administration.

7.0 REFERENCE(S):
7.1 SOP: Movement of Material.
7.2 SOP: Requisition, Issuance and Archival of Batch Manufacturing and Packaging Records.

8.0 ANNEXURE(S):
Annexure no. Tittle of Annexure Format no. Mode
of Execution
Requisition sheet for Raw / Packing material for
Annexure I performing machine trial within or outside from Controlled format
factory premises
Annexure II Trial \ Engineering Record Controlled format
Annexure III Proposal Request for Trial / Engg / Pre-Exhibit Batch Controlled format

Annexure IV Proposal Request for Trial Batch (Outside) Controlled format

 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

9.0 DISTRIBUTION:
9.1 Master copy : Quality Assurance.
9.2 Controlled copy(s): Production department (01), Quality Assurance (01).
9.3 Reference copy (s): Production department 01), Utilities (01), Store (01), P&A (01)

10.0 REVISION HISTORY:

S.No. Version Change Reason(s) for Details of Revision Effective

No. Control No. revision date
01 00 New SOP NA
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

ANNEXURE I

Requisition sheet for Raw/Packing material for performing machine trial within or outside from factory premises

Reason for issuance: Batch no.:

S.No. Item code Item Name UOM Required Issued Qty A.R. Number Issued by. Checked by Verified by
Qty.

Prepared By Checked By Sign/Date Approved By Sign/Date

Sign/Date HOD QA Store Plant Head Head QA
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Assay Calculation: For Exact Quantity of API_____________________

The below calculation is to be used when standard quantity of API is to be dispensed is available from one A. R. No.

Assay on anhydrous/dried basis (a1): _______% Done By Checked By

Assay on as such basis (c1):
A. R. No.:
c1 = a1 X (100 – b1) = ________%
__________
100
Water/LOD (b1): _________%

Quantity of ‘API’ to be dispensed eq. 100% assay basis (A1) = Std. Qty X 100 = ____________________
C1
Extra quantity of ‘API’ dispensed is (X1) = (A1) – (Std. Qty.) = ___________-

X1 = _____________ Kg

Excipients Name:;- ________________________________

Quantity of ‘Excipients’ to be dispensed (B1)
B = ______________________ – (X1)]
B = ________________ Kg
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Assay Calculation: For Exact Quantity of API_____________________

The below calculation is to be used when standard quantity of ‘API’ is to be dispensed is not available from one A. R. No.
Assay % on Quantity on 100 %
Assay on
Available Water/LOD as such basis assay basis
A. R. No. anhydrous/dried Done By Checked By
Quantity (e1) (b1) % (c1) = a1X(100- b1) (d1) = (e1) X (c1)
basis (a1) %
100 100

e1A= d1A=

e1B= d1B=

e1C= d1C=

Total Available Quantity (e1) Total Quantity (d1)

e1 = (e1A+e1B+e1C) = d1 = (d1A+d1B+d1C) =

Remaining theoretical quantity of API required (f1) = Std. Qty. - (d1)

(f1) = ___________ - ___________ = _____________ Kg.

Next A. R. No.: Assay on anhydrous / dried basis (a12): _______% Assay on as such basis (c12):

Water / LOD (b12): _________% c12 = a12 X (100- b12) = ________%

__________ 100
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Actual Quantity of this A.R. No. to be dispensed (h1) = (f1) X 100 = _____________ Kg
(c12)

Therefore total quantity of ‘API’ dispensed (A1) = (e1) + (h1)

A1 = ___________ + ___________ = ____________ Kg

Extra quantity of ‘API’ dispensed is (X1) = (A1) –__________ = ___________

X1 = _____________ Kg

Excipients Name:;- ________________________________

Quantity of ‘Excipients’ to be dispensed (B1)
B = [______________________ – (X1)]
B = ________________ Kg
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

ANNEXURE II
Trial \ Engineering Record
Batch No. : BTZ_________

Issued By :

Line Clearance
Area Name:-
Date:-

Equipment Name Equipment Id. Cleaning SOP No. Operation SOP No.

Put ‘√’ if complies and put ‘X’ if does not complies in the check box.

Batch No.:
Previous Product : ______________________
___________________
Check the following and take line clearance from Q.A as per SOP …………

Removal of previous product and batch □ Equipment cleanliness □ Area cleanliness □ Status

Labeling □ Environmental condition □ Balance calibration record □ Equipment log sheets

Rinse Report AR No. :

Checked By (Dept.) Approved By (QA)

Sign / Date Sign / Date
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Instructions:
Follow these general precautions before starting the process.
1. Ensure that the secondary gowning of the respective area if followed.
2. Wear hand gloves, nose mask and safety goggles, and ear muffs (if required)
3. Ensure that the equipment’s are cleaned and having status label.
4. Ensure the environmental conditions of the particular area. Record in the appropriate area logbook.
Process:
Equipment Usage Details:

Equipment Name/ Others Identification No.

 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Raw Material Sifting Record:-

Vibro – Sifter ID No.:
1.1.1.1.1.1.1.1.1 ..…/…/…/______
(Microcrystalline Date:
Cellulose, Silicified Microcrystalline Cellulose and Croscarmellose
Sodium)
Sifting started at: Sifting completed at:

Remark :-

Checked by :-

Raw Material Co-sifting Record

Vibro – Sifter ID No.: …./…./…./______ Date:

1.1.1.1.1.1.1.1.2 (Microcrystalline Cellulose, Silicified Microcrystalline Cellulose and Croscarmellose
Sodium)
Sifting started at: Sifting completed at:

Remark:

Checked by:

Granulation Parameters:-

Dry Mixing & Granulation

Binder addition time

Granulation Time

Additional Water/IPA etc. qty. used (if required)

Additional Water/ IPA etc. qty. addition time

Granulation time (if required)

Total granulation time

Agitator Amperage
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Chopper Amperage

Extrusion and Spheronization

Length of Extrudes (mm)

Roller speed (RPM)

Speed (RPM)

Drying (FBD)

Inlet Temperature

Outlet Temperature

Total Drying Time

Drying (VTD)

VTD chamber temperature

Hot water inlet temperature

Vacuum Pressure

Process Step Description Done By Checked By

(Sign / Date)
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

LINE CLEARANCE FOR COMPRESSION AREA Date: ____________

Equipment Name Equipment ID No. Cleaning SOP No. Operation SOP No.
…./…./…./____ PG/___ PG/___

…../…./…./____ PG/___ PG/___

S. S. Container PG/___ NA

Area

Line Clearance Tablet Compression

Previous Product: Batch No.:

Checked By (Production) (Sign & Date) Approved By (QA) (Sign & Date)

Machine Start Up & End Details

Started At Completed At Checked
Done By Checked By Done By
Date Time Date Time By

Compress the whole batch with the above specification as given in table.
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Before Compression Punch, Die and Cap Inspection Done By: - _______________________

Ist Start-up Test During Tablet Compression 2nd start up

Specification Time:- Date:- Time:- Date:-
Equipment
S.No. Test Observations Observations
ID No.

Appearance:

1. .

Uniformity
of Weight
2. of____
Tablets

Minimum: Maximum: Minimum: Maximum:

Average
Weight of
3. ___ _____________________mg _____________________mg
Tablets

Weight of
4. ______ ______________________g ______________________g
Tablets

Thickness
of ______
5.
Tablets

Minimum: Maximum: Minimum: Maximum:

Table No.: 3.4.1 - 1st Start-up Test During Tablet Compression (Verification
2nd start up
of Tablet Parameters) Contd……………
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Equipment ID
Test Observations Observations
No.

Diameter of
_____
Tablets

Minimum: Maximum: Minimum: Maximum:

Hardness of
______
Tablets

Maximum
Minimum: Maximum: Minimum:
:
Friability
NMT 1%
w/w
Machine
Speed _______________ RPM _______________ RPM
(RPM)
Hydraulic
Pressure ________________ KN ________________ KN
(KN)
Specification Parameters Tablet Parameters Tablet Parameters
Verified By: Checked By: Checked By:
Sign & Date Sign & Date Sign & Date
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

IN-PROCESS CHECKS
Machine Parameter Appearance of the Tablets (Defects)
Date Time Machine Hydraulic
Broken % Ckd
Speed Pressure Capping Chipping Sticking Discoloration
Tablets Defects By
(RPM) (KN)
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

IN-PROCESS CHECKS (Thickness, Hardness and Friability)

Friability
Thickness (mm) Hardness
Date Time NMT 1.0 % w/w Ckd By
Equipment ID No.: Equipment ID No.:
Equipment ID No.
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

IN-PROCESS CHECKS (Thickness, Hardness and Friability)

Friability
Thickness (mm) Hardness
Date Time NMT 1.0 % w/w Ckd By
Equipment ID No.: Equipment ID No.:
Equipment ID No.
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Procedure (To filled for activity which cannot be recorded in above format)

Process Step Description Checked By

Done By
(Sign / Date)

Reviewed By Checked By Approved By

Deptt. Deptt. Deptt.
Sign/Date Sign/Date Sign/Date
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Destruction of Batch

Date of destruction :

Mode of destruction:

Approved By
Supervised by
IPQA Head, Production

Sign/Date Sign/Date
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

COATING Date:
Coating Solution Preparation Record
Pneumatic Stirrer ID: Date:-

Step Quantity Time Done Checked

Description
No. (Kg) From To By By

Coating Cycle Details

Started At Completed At Checked By
Done By
Date Time Date Time (Production)

Coating Details Date:-

Checked
Stage Started At Completed At Done By
By
Loading

Preheating

Coating

Drying

Cooling
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

In-process Checking Record During Film Coating

Pump RPM
Inlet Temp.

Spray Rate
Atomisatio
Bed Temp.

Tablets (g)
n Pressure

Wt. of 100
Peristaltic

(______RPM)
Pan RPM
(_____RPM)

Inlet Air

Done By
(g/gun/min)

Velocity
Exhaust
Velocity
Supply
(_______
Temp.
Outlet

Kg/cm2)
Time

(RPM)

(RPM)
Date

Ckd
Air

By
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

In-process Checking Record During Film Coating

Pump RPM
Inlet Temp.

Spray Rate
Atomisatio
Bed Temp.

Tablets (g)
n Pressure

Wt. of 100
Peristaltic

(______RPM)
Pan RPM
(_____RPM)

Inlet Air

Done By
(g/gun/min)

Velocity
Exhaust
Velocity
Supply
(_______
Temp.
Outlet

Kg/cm2)
Time

(RPM)

(RPM)
Date

Ckd
Air

By
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

IN-PROCESS CHECKS AFTER COATING

Equipment Observations Observations
S.No. Test
ID No. 1st start up 2nd start up
Appearance:

1.

Weight of 20
2. ________________ g ________________ g
Tablets

Thickness of
3. 20 Tablets

Minimum: Maximum: Minimum: Maximum:

Uniformity of
Weight of 20
4. Tablets

Minimum: Maximum: Minimum: Maximum:

Average
5. Weight of 20 A1________________ mg
Tablets

Tablet Parameters Checked

Tablet Parameters Checked By:-Sign & Date
By:-Sign & Date
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Procedure (To filled for activity which cannot be recorded in above format)

Checked By
Process Step Description Done By
(Sign / Date
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Packing:
Line Clearance
Area Name:
Date:-

Equipment Name Equipment ID Cleaning SOP No. Operation SOP No.

Put ‘√’ if complies and put ‘X’ if does not complies in the check box.

Previous Product : ______________________ Batch No.: ______________________

Check the following and take line clearance from Q.A as per SOP No……….

Removal of previous product and batch □ Equipment cleanliness □ Area cleanliness □ Status

Labeling □ Environmental condition □ Balance calibration record □ Equipment log sheets

Rinse Report AR No. :

Checked By (Dept.) Approved By (QA)
Sign / Date
Sign / Date
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Process Step Description Checked By

Done By
(Sign / Date)

Reviewed By Checked By Approved By

Deptt. Deptt. Deptt.
Sign/Date Sign/Date Sign/Date
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Destruction of Batch

Date of destruction :

Mode of destruction:

Supervised by Approved By
IPQA Head, Production

Sign/Date Sign/Date
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

ANNEXURE III
Proposal Request for Trial / Engg / Pre-Exhibit Batch

Document No.: ______________

Section - 1 (To be filled by Production)

Initiated By:
Name: Sign. Date:

Proposed plan:- Trial / Engg / Pre-Exhibit Batch

1. Purpose of Plan:-

2. Equipment Usage Details (include all major equipment to be used) (use additional pages, if required and
provide details are per format given below)

S.No. Equipment Name Equipment ID

3. Brief description of process to be followed or provide / attach reference procedure to be followed (attach
additional sheets as per requirement)

4. Requirement of BMR:- Yes/No

If yes, mention BMR no.-

5. Batch Size :
6. Material Usage details

a. Obtained from R&D/ Other Site: Yes / No. If yes, provide details. If No, move to part b.

b. Proposed BOM with quantity, API details, etc., ((attach additional sheets as per requirement)
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

S.No. Ingredients UOM Quantity Item code (If available)

Verified by
Production (Sign/Date) QA (Sign/Date)
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Section - 2 (To be filled by Quality Assurance)

Quality Assurance shall review the impact of proposed impact on the following :
1. Impact on existing license : Yes/ No

2. Impact on Qualification of equipment/ area : Yes/ No

3. Impact of Cleaning Procedures of equipment/ area : Yes/ No

4. Impact on Cleaning Validation/ Verification : Yes/ No

5. Other :

6. Sampling and testing requirements, if any:- Yes/No, If yes QA shall provide the sampling protocol approved
by Head Production / Designee

7. Review required by other Dept. : Yes / No (if yes, list the department)

Approved By Head Quality assurance (Sign/Date):-

Section - 3 (Review by Other Departments)

Department Name :
Comments :

Sign/ Date :
Department Name :
Comments :

Sign/ Date :
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Department Name :
Comments :

Sign/ Date :
Department Name :
Comments :

Sign/ Date :
Department Name :
Comments :

Sign/ Date :
Department Name :
Comments :

Sign/ Date :
Department Name :
Comments :

Sign/ Date :
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Section - 4 (Disposition of Proposal)

Comments by Plant Head :

The proposal is Accepted/ Not Accepted

(Sign/ Date)

Comments by Head QA :

The proposal is Accepted/ Not Accepted

Head QA (Sign/ Date)
If approved, activities to be undertaken:
License Availability :
Line Clearance Checklist :
Cleaning Checklist/ Procedure :
Cleaning Method Validation / Verification :
Testing Method Validation / Verification :
Qualification activities :
Specification :
Item Code Requirement :

On approval, the initiator department shall commence trial, when the above mentioned activities are
completed. The issuance of material and recording of details shall be as per Annexures to the SOP
No. Batch No. shall be allocated by QA.
Batch no. allotted by QA : BTZ____________
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

ANNEXURE IV
Proposal Request for Trial Batch (Outside)
Document No.:____________________

Section -1 (To be filled by Production)

Initiated By:
Name: Sign. Date :
Proposed plan for Trial
7. Purpose of trial :

8. Material Usage details

c. Obtained from R&D/ Other Site: Yes / No. If Yes, provide details. If No , move to part b.

d. Proposed BOM with quantity, API details, etc., ((attach additional sheets as per requirement)

S.No. Ingredients UOM Quantity Item code (If available)

Approved By (Head, Production/ designee):

 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Section - 2 (Reviewed by Quality Assurance)

Comments: :
Review required by other Dept. : Yes / No (if yes, list the name of department)

Reviewed By (QA) : Approved By (Head, QA) :

Section -3 (Review by other Departments)

Department Name :
Comments :

Sign/ Date :
Department Name :
Comments :

Sign/ Date :
Department Name :
Comments :

Sign/ Date :
 PHARMA DEVILS
PRODUCTION DEPARTMENT

STANDARD OPERATING PROCEDURE

Department: Production SOP No.:
Title: Conducting of Manufacturing / Packing Trials Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Department Name :
Comments :

Sign/ Date :
Final Review Plant Head
Comments :

The proposal is Accepted/ Not Accepted

Reviewed on Sign/ Date :

Section - 4 (Disposition of Proposal)

Comments by Head QA :

The proposal is Accepted/ Not Accepted

Approved By (Head, QA) :