ESEHI PHARMACEUTICAL INDUSTRIES LIMITED

STANDARD OPERATIONAL PROCEDURE

TITLE Department Quality Assurance
S.O.P No. EQA-027
Revision No. 02
Effective Date 25/05/2015
IN-PROCESS CHECKING Supersedes 25/05/2013
Review Date 25/05/2017
Page Number 1 of 3

1.0 OBJECTIVE: To provide a written guideline for in-process checks.

2.0 SCOPE : The procedure is applicable to all processes involved in the formulation unit
to ensure that the system are being followed without any deviation whatsoever

3.0 RESPONSIBILITY: It is the responsibility of the QC manager and the in-process

officer

4.0 PROCEDURE:
1. The in-process officer should check all the process areas of production, at least
twice in a shift.
2. The in-process officer should check for cleanliness of the area, any deviation from
the standard laid down procedure should be reported and corrected immediately on
priority through proper line of authority.
3. The inspector should check for some critical parameters in the process areas for
example,
BATCH CODING SECTION
Quality of batch coding, any omission of numbers, correctness of details,
reconciliation of printing rejections records etc.
DISPENSING SECTION
Quality of dispensed materials, status label of the dispensed materials and
confirmation of quality control passed material being used, calibration of weighing
Balance
MANUFACTURING SECTION
Checking of BMRs, fill weight in dry syrup/liquid products, tablet rejection in
suspension, weight variation in compression.
PACKAGING SECTION
BPR checking, packaging operations ,leaks testing of bottles

PREPARED BY APPROVED BY AUTHORISED BY

NAME MRS EHIGIAMUSOE O. MR. ISIBOR HUMBERT PHARM. DADA TOLUWASE

SIGN.
DATE
 ESEHI PHARMACEUTICAL INDUSTRIES LIMITED
STANDARD OPERATIONAL PROCEDURE
TITLE Department Quality Assurance
S.O.P No. EQA-027
Revision No. 02
Effective Date 25/05/2015
IN-PROCESS CHECKING Supersedes 25/05/2013
Review Date 25/05/2017
Page Number 2 of 2

QUALITY CONTROL DEPARTMENT

1. Confirmation of calibration activities , ensuring STP Standard testing procedure is
being followed any deviation
2. Prescribed in-process quality control formats are to be documented by the IPQC
inspectors and should be attached to every batch document.
3. IPQC inspectors should record the observations in daily IPQC report and should
submit the same to quality assurance manager for necessary review and actions

5.0 REFERENCES:
www.pharmaceuticalguidelines.com

6.0 ANNEXURES:
Not applicable.

7.0 ABBREVATIONS:
7.1 STP: Standard Testing Procedures
7.2 IPQC: in process Quality Control
7.3 BPR: Batch packing records
8.0 REVIEW HISTORY
Inclusion of reference
Re-validated as time of active validity elapsed

9.0 TRAINING REQUIREMENT

Training to be conducted after every review and as documented in the staff training schedule

PREPARED BY APPROVED BY AUTHORISED BY

NAME MRS EHIGIAMUSOE O. MR. ISIBOR HUMBERT PHARM. DADA TOLUWASE

SIGN.
DATE