Sop Forms
Sop Forms
S.No Employee Employee Designation Department Shift Date of Time Time Signature
ID Name Attendance In Out
Prepared by:
Reviewed by:
Training Summary
Training Training Trainer Training Training Duration Completio Evaluation Remarks
Title Date(s) Type Location n Status
Supervisor/Manager Comments:
Employee Acknowledgement:
I acknowledge that I have completed the training sessions listed above and understand the
skills and procedures required.
Employee Signature: _____________________ Date: ______________________
Prepared by:
Reviewed by:
Evaluation Criteria
Please rate the following aspects of the training on a scale of 1 to 5:
1 = Strongly Disagree | 2 = Disagree | 3 = Neutral | 4 = Agree | 5 = Strongly Agree
Criteria Rating Comments (if any)
The training objectives were clearly defined.
The content was relevant to my job role.
The material was easy to understand.
The training duration was appropriate.
The trainer was knowledgeable and effective.
There were enough practical examples and exercises.
The training environment was comfortable.
The training has improved my knowledge and skills.
I will be able to apply the learning on the job.
Prepared by:
Reviewed by:
Feedback Questions:
1. How would you rate the overall quality of the training?
● Excellent [ ]
● Good [ ]
● Average [ ]
● Poor [ ]
● Very Poor [ ]
● Very Relevant [ ]
● Somewhat Relevant [ ]
● Not Relevant [ ]
3. How would you rate the trainer’s ability to deliver the content?
● Excellent [ ]
● Good [ ]
● Average [ ]
● Poor [ ]
● Very Poor [ ]
4. Were the training materials (handouts, slides, etc.) helpful and easy to
understand?
● Yes [ ]
● Somewhat [ ]
● No [ ]
● Too Long [ ]
● Just Right [ ]
● Too Short [ ]
Republic of the Philippines
MEDBUG PHARMACEUTICAL COMPANY
Kabacan, Cotabato
● Exceeded Expectations [ ]
● Met Expectations [ ]
● Below Expectations [ ]
7. How confident are you in applying what you learned in the training to your job?
● Very Confident [ ]
● Somewhat Confident [ ]
● Not Confident [ ]
8. How do you rate the facilities and environment provided for the training?
● Excellent [ ]
● Good [ ]
● Average [ ]
● Poor [ ]
Open-Ended Feedback:
9. What did you find most beneficial in this training?
10. What areas do you think could be improved in future training sessions?
11. Do you have any additional comments or suggestions?
Overall Rating:
Prepared by:
Reviewed by:
Prepared by:
Reviewed by:
Head of Production
Pre-production Checklist
Date: ________________________________
Remarks:
Prepared by:
Reviewed by:
Dispensing Log
Date: ___________________________
Remarks:
Prepared by:
Reviewed by:
Mixing Log
Date: ___________________________
Batch Number: ___________________________
Duration (Min)
Temp. (°C)
Remarks:
Prepared by:
Reviewed by:
Filling
Sealing
Labelling
Batch Number
Production Date
Expiry Date
Remarks:
Prepared by:
Reviewed by:
Inspection Report
Republic of the Philippines
MEDBUG PHARMACEUTICAL COMPANY
Kabacan, Cotabato
Date: ___________________________
Bottle Integrity
Seal Integrity
Label Accuracy
Label Placement
Random Sampling
Summary of Inspection:
Actions Taken:
Prepared by:
Reviewed by:
Storage Log
Republic of the Philippines
MEDBUG PHARMACEUTICAL COMPANY
Kabacan, Cotabato
Date: ___________________________
Storage Condition
Temp. (°C)
Humidity (%)
Remarks:
Prepared by:
Reviewed by:
A. Header Section
Product Name: Approved By:
2. Area Cleanliness:
Is the manufacturing area clean and sanitized? Yes/No
Checked by:
2. Mixing:
Start Time: HH:MM
End Time: HH:MM
Mixing Speed: rpm
Duration: minutes
Checked by:
Verified by:
3. Filtration:
Filtration Start Time: HH:MM
Republic of the Philippines
MEDBUG PHARMACEUTICAL COMPANY
Kabacan, Cotabato
F. Packaging Section
1. Bottle Filling:
Start Time: HH:MM
End Time: HH:MM
Number of Bottles Filled: No. of Bottles
Checked by:
Materials Required
Material Material Unit of Required
Item No. Quantity Purpose
Description Code Measure Date
1
2
3
4
5
Approval Section
Approved By Signature Date
Manufacturing Supervisor
Quality Assurance Manager
Finance Manager
Remarks:
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
Prepared by:
Reviewed by:
Item Details
Quantity Expiry
Item No. Description Unit Batch No. Remarks
Received Date
1
2
3
4
5
Acknowledgement
● Received By:
● Quality Check Conducted By:
● Quality Check Date:
● Comments on Quality:
Prepared by:
Reviewed by:
1. Manufacturing Details
Manufacturing Date:
Quantity Produced:
Production Line:
3. Compliance Verification
Labeling: [Yes/No]
Packaging: [Yes/No]
Date of Expiry: [Insert Date]
4. Release Authorization
Name Position Signature Date
Quality Control
Officer
Production
Supervisor
Warehouse Manager
5. Distribution Details
● Distribution Date:
● Transport Mode:
● Destination:
● Quantity Released:
Prepared by:
Reviewed by:
CERTIFICATE OF ANALYSIS
Product: LAGUNDI (Vitex negundo) SYRUP
Packaging & Labeling Materials:
Date of Analysis:
Batch Number:
Supplier:
Material Description:
Quantity Analyzed:
Unit:
Test Method:
TEST
SPECIFICATION RESULT PASS/FAIL COMMENTS
PARAMETER
Overall Assessment:
Pass: All test parameters meet specifications.
Fail: One or more test parameters do not meet specifications.
Analyst: ___________________________
Date: ______________________________
Approved by: _______________________
Date: ______________________________
Comments:
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
DATE: LISTER:
Estimated
Classificatio Delivery
Code Number Address reached Sender Handler Remarks
n Time
time
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
Inspection Results:
● Visual Inspection:
● Labeling:
● Expiration Date:
● Other:
Receipt Approval:
● Approved:
● Rejected:
DEVIATION REPORT
Format No. 1
Date:____________________ Control No.:________________
Republic of the Philippines
MEDBUG PHARMACEUTICAL COMPANY
Kabacan, Cotabato
Details of Purchased
Representative Filing Report Reporting Location Job No.
Product From
DEVIATION REMARKS
Quantity
Size
Shape/Specific
Color
Damage
Delivery
Mixed
Other
DEVIATION DETAILS
Correction
Estimates Recommendations
Credit Amount
Repair/Concessions
Replace/Concession
Other
DATE: LISTER:
Estimated
Delivery
Code Classification Number Address reached Sender Handler Remarks
Time
time
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
Inspection Results:
● Visual Inspection:
● Labeling:
● Expiration Date:
● Other:
Receipt Approval:
● Approved:
● Rejected:
STORAGE CONDITIONS
FIFO (First In, First Out) System: Oldest stock is used first
Storage Locations:
Storage Conditions: Inspection Results:
● Temperature: °C____ _____ ● Visual Inspection:
● Humidity: % ● Labeling: ____________________
● Other: ● Expiration:
● Other:
DOCUMENTATION COMMENTS
1) Master Record Index
2) Device Master Record (Overall Review)
3) Verified Device Specifications
4) Verifies Test and Inspection Procedures
5) Production Validation Documentations
6) Labels, Artwork
7) Packaging
8) Purchase Specifications
9) Vendor Evaluations
10) SOP & QA Manual Reference
MANUFACTURING
1) Equipment Qualification
2) Personnel Training
3) Process Validation
4) Pilot Production
5) Pilot Release
REGULATORY
1) FDA Premarket Approval
SERVICE
1) Servicing Plan
2) Personnel Trained
* The following abbreviations may be used the comment column to save time.
U = Unsatisfactory
NI = Needs Improvement
NA = Not Applicable
S = Satisfactory
Storage Conditions:
● Temperature:_________________
● Humidity:___________________
● Lighting:____________________
● Ventilation:__________________
● Pests:_______________________
Inspection Results:
Quantity Used:
● Unit of Measure: (e.g., Pieces, Boxes)
● Date Used:
● Quantity Remaining:
Quantity Remaining:
● Unit of Measure: (e.g., Pieces, Boxes)
● Expiry Date:
● Comments:___________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
Approved by:_____________________
Date:___________________
STORAGE CONDITIONS
FIFO (First In, First Out) System: Oldest stock is used first
Overall Assessment:
Pass: Storage area meets all requirements.
Fail: Storage area does not meet all requirements.
DISTRIBUTION
ORDER FORM
Company Name: MEDBUG PHARMACEUTICAL COMPANY
Address:_________________________________________________________
Contact Number: _______________________________________
Email: _______________________________________
Republic of the Philippines
MEDBUG PHARMACEUTICAL COMPANY
Kabacan, Cotabato
Website: _______________________________________
Order Information
Order Number: ___________________
Order Date: ___________________
Requested Delivery Date: ___________________
Distributor Informatio
Distributor Name: ___________________
Distributor ID: ___________________
Contact Person: ___________________
Phone Number: ___________________
Email: ___________________
Delivery Address:
Product Details
Product Code Product Name Quantity Unit Price Total Price
Delivery Instructions
Terms & Conditions
1. All orders are subject to availability.
2. Payments must be made in full before delivery unless otherwise agreed.
3. Any damages or discrepancies must be reported within 24 hours of receiving the
goods.
4. [Additional Terms & Conditions]
Prepared by:
Reviewed by:
Dispatch Information
Dispatch Number: _______________
Order Number: __________________
Dispatch Date: ___________________
Carrier/Transport Company: ___________________
Vehicle Number: _________________
Driver's Name: ___________________
Contact Number: ________________
Product Details
Product Product Quantity Quantity Batch Remarks
Code Name Ordered Dispatched Number
Documentation Checklist
Document Status (Attached/Not Attached) Remarks
Invoice [ ] Attached [ ] Not Attached ___________
Packing List [ ] Attached [ ] Not Attached ___________
Delivery Note/Challan [ ] Attached [ ] Not Attached ___________
Quality Check Report [ ] Attached [ ] Not Attached ___________
Certificate of Analysis ( if [ ] Attached [ ] Not Attached ___________
applicable)
Dispatch Verification
Item Verified By Signature Date
Product Quantity
Product Quality
Packaging
Documentation
Transport Details
Transport Company: __________________________
Driver Name: __________________________
Vehicle Number: __________________________
Departure Time: __________________________
Final Authorization
Republic of the Philippines
MEDBUG PHARMACEUTICAL COMPANY
Kabacan, Cotabato
Prepared by:
Reviewed by:
Product Details
Delivery Status
Item Status (Yes/No) Remarks
Products Delivered in [ ] Yes [ ] No
Good Condition
All Items Accounted for [ ] Yes [ ] No
in Delivery
Product Packaging Intact [ ] Yes [ ] No
Any Discrepancies in [ ] Yes [ ] No
Delivery
Additional Notes/Comments
Customer Acknowledgement
I, the undersigned, confirm that I have received the products listed above in the quantities
specified and in good condition.
Date: _____________________
Authorized by (Company)
Prepared by:
Reviewed by:
Transport Information
Republic of the Philippines
MEDBUG PHARMACEUTICAL COMPANY
Kabacan, Cotabato
Product Details
Product Code Product Name Batch Number Quantity
Driver’s Remarks:___________________________________________________________________________
I, the undersigned, confirm that the products were received under the conditions specified
in this form.
Transporter's Signature
Prepared by:
Reviewed by:
TO: FROM:
We are hereby RETURNING the above goods on account of defects in goods stated as
follows:
Credit for the products returned is hereby claimed and demanded. Such claim does not
limit our rights to further credits or damages in the event that additional credits or
damages are discovered to be due or additional retums are made. Settlement with or
release to you does not walve any rights against any other party. All rights are reserved
cumulatively and not exclusively. Nothing contained herein shall alter any other
documentation issued by us, unless specifically so stated.
This notice is made under the [CODE] (if applicable) and all other applicable laws.
RETURNING PARTY
by:
Problem Statement
o (briefly describe the incident or problem)
Republic of the Philippines
MEDBUG PHARMACEUTICAL COMPANY
Kabacan, Cotabato
Data Collection
o (list any data, reports, or evidence gathered)
o Witnesses (list the factors that led directly to the incident)
Action Plan
● (list actions to address root causes)
● (who will implement these actions)
● Deadline for implementation
Follow-up
● (describe whether actions were implemented and their effectiveness)
Prepared by:
Reviewed by:
Recall Overview
Republic of the Philippines
MEDBUG PHARMACEUTICAL COMPANY
Kabacan, Cotabato
Product Information
● (list specific details about the products involved in the recall, including batch/lot
numbers)
● (total number of units recalled)
Recall Execution
● (describe the methods used to notify customers and retrieve the product)
● (specify communication channels used)
● (percentage of customers who responded to the recall notification)
Outcome of Recall
● (number of units successfully returned)
● (total number of units disposed of after return)
● (units still in circulation or unaccounted for)
Final Remarks
● (lessons learned)
● (additional comments)
Prepared by:
Reviewed by:
Supplier: _______________________________________
Remarks:
Prepared by:
Reviewed by:
Appearance: _______________________
Color: _______________________
Odor: _______________________
Remarks:
Prepared by:
Reviewed by:
Results: _____________________________
Pass/Fail: _____________________________
Remarks:
Prepared by:
Reviewed by:
Date: ____________________________
Results: _____________________________
Pass/Fail: _____________________________
Remarks:
Prepared by:
Reviewed by:
Test Conducted:
- Physical Inspection
- Sample ID: ____________
- Results: ____________
Republic of the Philippines
MEDBUG PHARMACEUTICAL COMPANY
Kabacan, Cotabato
- Pass/Fail: ____________
- Actions Taken: ____________
- Remarks: ____________
- Chemical Analysis
- Sample ID: ____________
- Results: ____________
- Pass/Fail: ____________
- Actions Taken: ____________
- Remarks: ____________
- Microbiological Test
- Sample ID: ____________
- Results: ____________
- Pass/Fail: ____________
- Actions Taken: ____________
- Remarks: ____________
Overall Conclusion:
Prepared by:
Reviewed by:
Signature: _____________________________
Remarks:
Prepared by:
Reviewed by:
Label Appearance:
● Color
● Clarity
● Adhesion
Republic of the Philippines
MEDBUG PHARMACEUTICAL COMPANY
Kabacan, Cotabato
Pass/Fail: ________________________
Inspector: _________________________
Signature: _____________________________
Prepared by:
Reviewed by:
Duration: _______________________________
Remarks:
Prepared by:
Reviewed by:
Date: ____________________________
Duration: ____________________________
Pass/Fail: ____________________________
Remarks:
Prepared by:
Reviewed by:
Test Conducted:
- Visual Inspection
- Sample ID: _________________________
- Results: _________________________
- Pass/Fail: ____________________________
- Actions Taken: _______________________
- Remarks: ________________________
- Adhesion Test
- Sample ID: _______________________
- Results: ________________________
Republic of the Philippines
MEDBUG PHARMACEUTICAL COMPANY
Kabacan, Cotabato
- Pass/Fail: ________________________
- Actions Taken: ________________________
- Remarks: ________________________
Overall Conclusion:
Prepared by:
Reviewed by:
Pass/Fail: _____________________________
Republic of the Philippines
MEDBUG PHARMACEUTICAL COMPANY
Kabacan, Cotabato
Remarks:
Prepared by:
Reviewed by:
Record Details
● (type of records – batch records, quality control records, training records)
● (brief description of the record)
● (specify the retention period – e.g. 5 years)
● (indicate the location of the records to be stored)
Compliance Information
● (regulatory requirement – list any applicable regulations or guidelines that dictate
retention requirements)
● (name and title of the individual responsible for maintaining the records)
Republic of the Philippines
MEDBUG PHARMACEUTICAL COMPANY
Kabacan, Cotabato
Acknowledgement
Prepared by:
Reviewed by:
Expiration Date:
1. BATCH DETAILS
Product description
Batch quantity
Packaging
Republic of the Philippines
MEDBUG PHARMACEUTICAL COMPANY
Kabacan, Cotabato
Storage condition
2. RAW MATERIALS
COUNTRY OF
QUANTITY BATCH NO. EXPIRY
DESCRIPTION ORIGIN REMARK
REQUIRED OF THE RM DATE
(MANUFACTURER)
3. PROCESSING EQUIPMENTS
EQUIPMENTS USED VERIFIED/CALIBRATED REMARK
4. PRODUCTION PROCESS
1. DISPENSING AND RAW PERFORMED BY: VERIFIED BY:
MATERIAL
PREPARATION
4. YIELD CALCULATION
pH Adjustment Log
SAMPLE NO. TIME INITIAL pH ADJUSTMENTS FINAL pH CHECKED
BY
Expiration Date:
Viscosity
Microbial Test
Assay
FILLING LOG
MEDBUG PHARMACEUTICAL COMPANY
Personnel Involved
Equipment Used
Signatures:
________________________ ________________________________
_________________________________
Filling Operator Quality Control Representative Supervisor
Personnel Involved
*Manual inspection
*Weight verification
*pH level check
*Container integrity
*Label accuracy
*Manual verification
Signatures:
________________________________ ________________________________
Quality Control Representative Supervisor
Expiration Date:
CALIBRATION REPORT
CALIBRATION EQUIPMENT/ SERIAL REFERENCE READING READING REMARKS
DATE INSTRUMENT NO. STANDARD (BEFORE (AFTER
USED CALIBRATION) CALIBRATION)
Republic of the Philippines
MEDBUG PHARMACEUTICAL COMPANY
Kabacan, Cotabato
Expiration Date:
5. BATCH DETAILS
Product description
Batch quantity
Packaging
Republic of the Philippines
MEDBUG PHARMACEUTICAL COMPANY
Kabacan, Cotabato
Storage condition
6. RAW MATERIALS
COUNTRY OF
QUANTITY BATCH NO. EXPIRY
DESCRIPTION ORIGIN REMARK
REQUIRED OF THE RM DATE
(MANUFACTURER)
7. PROCESSING EQUIPMENTS
EQUIPMENTS USED VERIFIED/CALIBRATED REMARK
8. PRODUCTION PROCESS
5. DISPENSING AND RAW PERFORMED BY: VERIFIED BY:
MATERIAL
PREPARATION
8. YIELD CALCULATION
Oral/Gustatory Interoception
Republic of the Philippines
MEDBUG PHARMACEUTICAL COMPANY
Kabacan, Cotabato
Condition of materials
Integrity (freefree from damage,
tears, etc.)
Quality of adhesive
Adhesion properties (labels
sticking properly)
Appropriateness of size
Size and Fit
and fit for the product
General impression of
Overall Satisfaction
the materials
Rating Scale:
1 - Poor
2 - Fair
3 - Good
4 - Very Good
5 - Excellent
Overall Assessment:
Pass: All sensory attributes meet specifications.
Fail: One or more sensory attributes do not meet specifications.
Equipment: _____________________________________
Inspection Items:
o Physical condition (cracks, dents, etc.)
o Cleaning effectiveness
o Sanitization effectiveness
Inspection Results:
● Satisfactory
Republic of the Philippines
MEDBUG PHARMACEUTICAL COMPANY
Kabacan, Cotabato
Inspector: _______________________
Signature: ______________________
Equipment: ________________________________________
Validation Parameters:
● Cleaning effectiveness
● Sanitization effectiveness
Validation Results:
● Meets specifications
Validation Team:
______________________________
___________________________
____________________________________
Sanitization Log
Observations
Sanitized By
Date (With Time
(With Supervisor's
(YYYY-MM- Equipment ID Started and
Sanitizing Signature
DD) Time
Agent used)
Completed
Republic of the Philippines
MEDBUG PHARMACEUTICAL COMPANY
Kabacan, Cotabato