RAIM HOMOEO LABORATORIES

Department Quality Control

Title SOP for SOP

Effective From : 01.01.2017

Name Sign / Date

Prepared By : Quality Control Officer

(Md. Anwar Hossain) ________________

Checked By : Manager, Production

(DR. Sukanto Paoul) ________________

Approved By : In-charge, Factory

(Kanchon Bhowumik) ________________

Authorized By : Managing Director

(Roton Bhowumik)
________________

_______________________________________________________________________________

Owner of the SOP : Quality Control

Cross Functional Area : Production, Planning, Quality Control,

Store Room and Administration

Distribution : Managing Director

In-Charge
Manager, Production
Quality Control Officer
Store Officer

1.0 OBJECTIVE

To provide standard operating procedure and responsibilities regarding preparation, authorization,

distribution control and revision of all SOPs.

2.0 SCOPE
This SOP is applicable for all departments of Raim Homoea Laboratories. Including Production,
Quality Control, Management, Planning, Store and Administration.

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Prepared by/ Date Checked by/ Date Approved by/ Date
 RAIM HOMOEO LABORATORIES

Department Quality Control

Title SOP for SOP

3.0 REFERENCE DOCUMENTS

Bangladesh Homoeopathic Pharmacopeia.

4.0 RESPONSIBILITIES/ACCOUNTABILITIES

4.1 Managing Director is responsible to identify the requirement of SOPs to select the person to
Prepare and technical review of SOPs.

4.2 MD and In-charge (Factory) and QC are responsible to approve the SOPs.

4.3 Quality Control Officer or his/her nominee is accountable to control, issue, distribution and archival
of SOPs.

4.4 Quality Control Officer is responsible to train his/her personnel about implementation of SOP
Before effective date.

5.0 PRECAUTIONS/ SPECIAL INSTRUCTION

5.1 SOPs has to be the written as per the real and better procedure of any activity/operation.

5.2 Preparation of new SOP(s) and revision of existing SOP(s) has to be performed by user
department.

5.3 Availability of relevant SOP has to be ensured at the users level.

5.4 Retrieval of superseded SOP from the concerned department shall be ensured.

5.5 Training has to be provided to the users before effective date of any SOP.

5.6 Format change of any SOP will not affect validity status of existing SOPs unless there is any
change needed.

6.0 PROCEDURE

6.1 Preparation of SOP

6.1.1 Quality Control Officer has to identify the requirement of a new or revision of a SOP.

6.1.2 To prepare SOP(s) and/or edit preformatted standard form shall be used. All pages of SOP(s)
shall be printed on pre-printed Portrait Master Document Form. All edit work, saving and filling
shall only be done in Microsoft Word for Windows within the preformatted standard form
available with QC department as soft copy.

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Prepared by/ Date Checked by/ Date Approved by/ Date
 RAIM HOMOEO LABORATORIES

Department Quality Control

Title SOP for SOP

6.1.3 The principles given in next page shall be followed during preparation of SOP(s) (Standard
Operating Procedure) shall be printed on A4 size (8.27 x 11.69 inches) white paper marked
diagonally at the center with Pantone shade 1807C colored CONFIDENTIAL and a Pantone
shade 1807C color band of width 6 mm, at the bottom bearing text Copies marked with this
Pantone shade 1807C band are the master document(s) with below mentioned standard page
format.

Left margin : 0.88 inch Top margin: 0.75 inch

Right margin : 0.52 inch Bottom margin : 0.56 inch

Header from edge: 0.7 inch Footer from edge: 0.9 inch

Vertical alignment of page: Center Font type : Arial

Font size of Text: 11 except company name

Standard Operating Procedure : Bold, capital

First page: Headings of Title, Page No., SOP No., Version No., Supersedes, Issue Date,
Revision Due, Effective Date, Prepared By, Checked By, Approved by,
Name, Designation and Sign & Date: Bold

From 2nd & Subsequent pages: Title, Page No., SOP No., Version No., Supersedes, Issue
Date, Revision Due : Bold

At the bottom: Prepared By, Checked By, Approved By: Bold

Company Logo: Standard uniform size on top of each page on left hand side.

Space of line after subheading: One enter space of single line spacing.

Space of line after heading: One enter space of single line spacing.

Each pages an external frame in single line (Width: 1 pt).

- 1st rate headings (e.g. Objective, Scope etc.): Bold, capital

- 2nd rate headings (e.g. Preparation of SOP, Approval of SOP): Bold, underlined

- 3rd rate headings (e.g. Objective, scope etc. under Preparation of SOP): Bold

- 4th rate headings: Normal

- Numerical sequencing shall be followed.

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Prepared by/ Date Checked by/ Date Approved by/ Date
 RAIM HOMOEO LABORATORIES

Department Quality Control

Title SOP for SOP

- SOP shall be written in clear, concise and simple language and shall be
Unambiguous.

- SOP shall be written in short sentence describing the activity properly.

- Title of SOP shall be short, specific and shall reflect accurately the content of
SOP(s).

- Each SOP number comprises of three sections / groups. The first section shall indicates in brief
of Standard Operating Procedure i.e. SOP and second section / group shall denote different units
/ departments / areas of Raim Homoeo Laboratories. The following code numbers for their
respective must be followed:

Production Department : PRD

Quality Control Department : QC
Store Area : SA
Marketing & Sales Department : MSD
Management Department : MD

- SOP Version No.: Version no. shall be given as 01, 02, 03 etc in this heading. For a new
SOP, version no. shall be 01. Revision of SOP shall be given with their next respective version
number.

- Supersedes: In this heading Version No. of the former SOP shall be written with date of issue
of that version. For a new SOP, None shall be written in this heading.

- Issue Date: It is the month in which the SOP is issued & is to be mentioned in the format of
DD/MM/YYYY (e.g. Jan 2017) in a pre-printed manner.

- Revision Due: The month in which the SOP should be reviewed and is to be mentioned in
this heading in the format of DD/MM/YYYY (e.g. Jan 2017). As a general rule, all SOPs shall
be reviewed in every three years. Revision may be done before due date if needed.

- Effective Date: It is the date on which the SOP is scheduled to be effective for adequate
training of users for implementation of any procedure regarding operation and It shall be in the
format of DD/MM/YYYY (e.g. 01.01.2017) . Photocopying of SOP has to be done after putting
the effective date of the SOP. In general, the effective date should not exceed 10 days from
the date of its authorization. In other words training should be provided within these 10 days.
Effectiveness of training must be evaluated and training attendance has to be part of the
master SOP (as an attachment).

6.1.4 All the SOPs shall be written with the following nine sub-headings

- Objective
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Prepared by/ Date Checked by/ Date Approved by/ Date
 RAIM HOMOEO LABORATORIES

Department Quality Control

Title SOP for SOP

- Scope
- Reference
- Responsibilities/Accountabilities
- Precautions/ Special Instructions
- Procedure
- Abbreviations And Definitions
- Revision History
- Appendices

These sub-headings shall contain the following in details -

Objective: The purpose of writing the SOP shall be mentioned under this heading,
starting with the word To.

Scope: This section shall define clearly for which area/equipment the SOP is
applicable.

Reference: Reference shall be mentioned where applicable. Otherwise None should be written.

Responsibilities/Accountabilities: Department head or his/her nominee is responsible to

ensure the implementation of the SOP.

Precautions/Special Instructions: This section shall define the necessity of taking any
precautionary measure for the intended activity or operation.

Procedure: Procedure pertaining to the objective of the SOP shall be described in detail, clear,
unambiguous and in user friendly English language.

Abbreviations and Definitions: The abbreviated word used in the SOP shall be written in
details under this section.

Revision History: Revision of SOP shall be done as and when necessary to incorporate
changes as per current regulatory requirements and on expiry of review period. Such revision
shall be given under this heading with proper reason for review.

Appendices: Appendices are for documenting any work or activity related to the SOP. The
master copy of Annexure is to be authenticated by signing (with date) by QC officer. This will be
having at least the SOP No. & Version No. at the top of the sheet. Appendices will be printed on
blank paper, not in preprinted form though these are part of SOP. Whenever, if there is a need for
making any modification in Appendix and it does not affect content of SOP, Appendix can be
revised with an amendment date & reason at the bottom of the page.

As a general practice this authenticated document has to be photocopied for routine usage.
Hence, for bulk usage, whenever outside printer is used a form no. shall be assigned for all the
formats (e.g. forms & labels) by QC. For example, Form No.FQCD00101 shall be the first version
of format FQCD001. The last two digits shall indicate the version number.
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Prepared by/ Date Checked by/ Date Approved by/ Date
 RAIM HOMOEO LABORATORIES

Department Quality Control

Title SOP for SOP

6.2 Approval of SOP

SOP shall be approved by signing each page. First page has to be signed by author, respective
department heads as a checker, Quality Assurance Manager will act as final checker and will
approve the document and Head of Plant Operation & Planning will authorize it. If the SOP is
cross functional for other departments, in first page signature has to be increased by including
the respective department heads as checker. Subsequent pages of a SOP have to be signed by
SOP author, respective department heads and QC.

The SOP shall be valid from effective date and date will be given by QA on the first page of the
SOP with authentication in the format of DD/MM/YYYY (e.g. 01/01/2017). Training has to be
completed before the effective date of the SOP. In general the time limit should not exceed more
than10 days from the approved date of any SOP.

6.3 Distribution and Control of SOP

6.3.1 Approved Master SOP (Hard & soft copy) of all departments shall be archived in Quality Control
Department.

6.3.2 The pertinent copy shall be distributed to the authorized person along with the Document(s)/
Data Acknowledgement Form by putting CONTROLLED seal in Red ink on every page of the
SOP mentioning copy no. with initial and date of SOP issuer of the QC department.

6.3.3 Photocopy of CONTROLLED SOP(s) is not permitted. If any additional copy is required, it
has to be copied from Master copy. For this case a request shall be obtained through a request
letter of the respective department head to QA Manager.

6.3.4 Document(s)/Data Acknowledgement Form shall be addressed to the concerned department

head/ section in-charge or the relevant person according to the distribution list of SOP. Retrieval
of all distributed old copies and their subsequent destruction by tearing off each page by four
parts (at least) has to be ensured during distribution of any SOP. QC is responsible to ensure
this till retrieval is completed. QA has to maintain a record of destruction of old copies.

6.3.5 Copy of the SOP for regulatory authority or for out of LEON control purpose shall be provided
with UNCONTROLLED COPY seal in red ink on every page of the SOP with initial and date of
SOP issuer of the QC department. Record of such distribution has also to be maintained by QC
Department.

6.4 Revision of SOP

6.4.1 At the end of validity all SOPs shall be reviewed by the signatories. If deemed necessary, SOP
shall be reviewed before the expiry of the validity period. With a subsequent revision number
shall be assigned in case of any revision. A revision detail (in brief) has to be summarized in
Revision history section of the SOP.

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Prepared by/ Date Checked by/ Date Approved by/ Date
 RAIM HOMOEO LABORATORIES

Department Quality Control

Title SOP for SOP

6.4.2 Master copy of obsolete SOP shall be kept in Obsolete SOP file in QA after stamping as
OBSOLETE on the front page of SOP with initial and date of Quality Assurance Manager or
his/her nominee. This has to be kept for 10 years after which these are to be destroyed.

6.4.3 Respective Departmental Heads are responsible to provide QC Officer a copy of In Use SOPs
whenever there is a change in SOP list. SOP list will contain SL No., SOP Ref, Title of SOP,
Version No, Issue Date & Revision Due.

7.0 ABBREVIATIONS AND DEFINITIONS

Standard Operating Procedure (SOP) : An authorized written procedure giving instructions for
performing operations not necessarily specific to a given product or material but of a more general
nature (e.g. equipment operation, maintenance and cleaning; validation; cleaning of premises and
environmental control; sampling and inspection etc).

8.0 REVISION HISTORY

SL.
Details of Revision Ref. no. with Version No.
No.
01 New SOP/QA/001; Version : 01

02 Format changed to make user friendly SOP for SOP SOP/QA/001; Version : 02

03 Routine Revision SOP/QA/001; Version : 03

9.0 APPENDICES

9.1 SOP format on Portrait Master Documents Form

9.2 Document/Data Acknowledgement Sheet

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Prepared by/ Date Checked by/ Date Approved by/ Date