CRADEL PHARMACEUTICALS PRIVATE LIMITED

STANDARD OPERATING PROCEDURE

QUALITY ASSURANCE

TITLE: DAILY INSPECTION

SOP No. : 1000XX
EFFECTIVE DATE. : DD/MM/YYYY
SUPERSEDES No. : NEW

ISSUE No. : 1000XX/0X

REVIEW DUE ON. : MM/YYYY
PAGE No. : Page 1 of 3

1.

Objective
To define the procedure for daily inspection to check the cGMP compliance.

2.

Scope
This procedure is applicable to Inspection on the GMP aspects of production activities at
Cradel Pharmaceuticals Pvt. Ltd., Kolkata.

3.

Responsibility
Executive QA
To prepare the cGMP noncompliance reports based on Daily inspection and submit the
report to concern Department.
To identify the cause and to recommend corrective action on inspected observation.
To follow-up and review the compliance of the Daily inspection findings on the given target
date.

4.

Accountability
Sr. Head-QA

5.5. Procedure
5.1 Inspection is conducted to determine whether the quality system requirements and regulatory
guidelines are effectively implemented, maintained and evaluated.
5.2 Inspection shall be conducted daily and followings activities must consider during inspection
(but not limited to) :
5.2.1 Compliance to SOPs.
5.2.2 Compliance to BPRs.
5.2.3 Status label.
5.2.4 Housekeeping record.
5.2.5 Compliance to GMP.
5.2.6 Daily Calibration record.
5.2.7 Temperature and Humidity.
5.2.8 Preventive maintenance etc.
5.3 The discrepancies / observations if any shall be entered on format No.: SPL/QA/019 by QA
and sent to concern department.
5.4 The concerned department and Q.A shall identify the root cause and fill the corrective action
accordingly.
Prepared By
Sign & Date
Name
Designation
Format No.: F100001/01/03

Checked By

Approved By

CRADEL PHARMACEUTICALS PRIVATE LIMITED

STANDARD OPERATING PROCEDURE

QUALITY ASSURANCE

TITLE: DAILY INSPECTION

SOP No. : 1000XX
EFFECTIVE DATE. : DD/MM/YYYY
SUPERSEDES No. : NEW

ISSUE No. : 1000XX/0X

REVIEW DUE ON. : MM/YYYY
PAGE No. : Page 2 of 3

5.5 The observation should be investigated and brought into the notice of head of QA.
5.6. All the observations to be evaluated and if required training to be imparted to the individual
or group.
6.

Records/Formats:
F1000XX/X/XX

7.

Daily Inspection Report

Annexure:
NA

8.

Reference:
Nil

9.

Abbreviations:

9.1. QA

Quality assurance

9.2. BPR

Batch Processing record

9.3. GMP

Good manufacturing Practice

10.

Revision History:
Revision No.
00

Effective Date

Revision History

Daily Inspection Report

Format No. F1000XX/X/XX
Area / Department: ________

Date: ________

Auditor/ inspector: ________

Prepared By
Sign & Date
Name
Designation
Format No.: F100001/01/03

Checked By

Approved By

CRADEL PHARMACEUTICALS PRIVATE LIMITED

STANDARD OPERATING PROCEDURE

QUALITY ASSURANCE

TITLE: DAILY INSPECTION

SOP No. : 1000XX
EFFECTIVE DATE. : DD/MM/YYYY
SUPERSEDES No. : NEW

Sr.
No.

Observation

ISSUE No. : 1000XX/0X

REVIEW DUE ON. : MM/YYYY
PAGE No. : Page 3 of 3

Root cause

Corrective
action

Target date

Follow up

Sign of auditor/Inspector

Sign of area in-charge

Sign of Head QA

Date

Date

Date

Root Cause code numbers: 1 Man 2 Machine 3 Material 4 Method

Prepared By
Sign & Date
Name
Designation
Format No.: F100001/01/03

Checked By

Approved By