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1.0 PURPOSE:
To establish a system for writing, approving, distributing and controlling of Standard
Operating Procedures (SOPs) as per regulatory requirements.
2.0 SCOPE:
This SOP is applicable to all SOPs governing various routine operations in different
departments and/or areas, which include Quality Assurance (QA), Manufacturing (MF),
Quality Control (QC), Analytical Development (AD), Packaging (PK), Warehouse,
Distribution and Shipping (WH), Regulatory Affairs (RA), Product Development (PD),
Human Resources (HR), Information & Technology (IT), Controlled Drug Substances
(CS) and Maintenance & Engineering (ME) procedures.
3.0 RESPONSIBILITIES:
3.1 It is the responsibility of each department personnel(s) to write, circulate to the
appropriate department’s personnel for review, approve and maintain the current SOP for
use by employees of the department.
3.2 It is the responsibility of the Quality Assurance department to review, approve, issue,
distribute and maintain the current revision of SOPs, retrieve and archive obsolete SOPs
and maintain a change control archive of all approved and distributed change notices.
3.3 It is the responsibility of each department supervisor and or appropriate personnel(s) to
Train department employees on current SOP for use. It is the responsibility of Quality
Assurance personnel to review and maintain the training records.
4.0 PROCEDURE:
4.1 General Information:
The SOP header shall contain the following:
4.1.1 Contains Ascent Pharmaceuticals, Inc. logo at the left top corner of the header.
4.1.2 Title: Give the detailed heading of the SOP
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4.1.3 SOP #: This is a unique number to each SOP which consists of six characters, the first
letter ‘A’ indicate the company name, next two letters indicate the concerned department;
next three digits indicate the sequential number assigned to the SOP. Each department is
abbreviated into three letters in parenthesis as followed:
1. Quality Assurance (AQA)
2. Quality Control (AQC)
3. Manufacturing (AMF)
4. Packaging (APK)
5. Warehouse, Distribution & Shipping (AWH)
6. Regulatory Affairs (ARA)
7. Product Development (APD)
8. Human Resources (AHR)
9. Information and Technology (AIT)
10. Controlled Drug Substances (ACS)
11. Maintenance & Engineering (AME)
e.g. AMF001 (This is the first SOP for Manufacturing department).
4.1.4 Revision #: which consists of two characters, the first number assigned for any new SOP
shall be numbered as ‘00’ and same when revised for first time shall be numbered as
‘01’and so on.
4.1.5 Effective date: is the date when contents of the SOP can be implemented or become
operative after training of the concerned personnel on SOP. The date shall be entered
manually or with a date stamp in MM/DD/YYYY format in blue/black color by QA

personnel.
4.1.6 Page #: gives the specific page number as well as the total pages comprising the standard
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operating procedure.
4.1.7 Written by/Date: The person who prepares the SOP shall sign with date in this column.
4.1.8 Reviewed by/Date: The reviewing authority usually will be respective department head
who will ensure the suitability of SOP is verified during review.
4.1.9 Approved by/date: Every SOP shall be approved with date by Head of Quality assurance
or his designee.
4.2 The Body of SOP should contain following:
4.2.1 PURPOSE:
A short paragraph defining the SOP’s purpose
4.2.2 SCOPE:
A short paragraph defining the area (department) and / or equipment covered by the SOP

4.2.3 RESPONSIBILITIES:
A paragraph indicating responsibilities of personnel related to follow or implement SOP.

4.2.4 PROCEDURE:
Standard Procedure section shall be simple, clear, direct, step-by-step narrative that
explains how to perform the tasks. It shall be stated in a concise but complete manner.
Diagrams, drawings, tabulations, data collection forms shall be stated as exhibits.
Safety information should be incorporated as necessary.

4.2.5 EXHIBITS:
Exhibits shall include attachments, annexure, appendices, formats or labels needed to
record compliance of the SOP. The exhibits which contain format or label shall be assigned
a number as below. All exhibits shall be numbered as A,B,C… or 1,2,3…for respective
SOP.
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1. Each exhibit (Label or format) shall be given a unique number. The number consists
of 13 characters:
2. The first three letters denote the department as mentioned in 4.1.3
3. The next three digits indicate the serial number of the SOP.
4. The seventh character is dash represented as ‘-’
5. The eighth character is ‘E’ denotes Exhibit (Format)
6. The ninth and tenth character denotes the serial number of the Exhibit of that
particular SOP.
7. The eleventh character is dash represented by ‘-’
8. The last two characters denote revision number of that respective Exhibit
Example: AQA001-E01-00 is the first Exhibit made for the first time and related to
first SOP of QA department.
9. The copy of each Exhibit shall be enclosed with respective SOP and shall be signed
by Head QA or designee by using ‘QA Approved’ stamp in green color.
4.2.6 REVISION HISTORY:
This shall contain Document Revision Number, description of changes made and effective
date of revision. This will usually be the last page of every SOP.

4.3 TYPING FORMAT:

Main titles, headings or important information may be highlighted and/or underlined. Each
main heading shall be numbered starting with the first section as 1.0, the second as 2.0 and
so on. Each subsection shall be defined as 1.1, the second subsection can be mentioned
with 1.1.1, 1.1.2, 1.1.3, … or a, b, c ….. or 1,2,3……or using bullets, etc.,
a) Header Font and Size: Times New Roman, 12 (Bold)
b) Body Text Font and Size: Times New Roman, 12
c) Margins Left and Right: 1" and 1"
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d) Margins Top and Bottom: 1.84" and 0. 88"

e) Spacing: 1.5 between lines and 1.5 spacing between paragraphs

NOTE: The contents and text of the SOP shall be written in black ink.

4.4 PROCEDURE FOR WRITING, REVIEWING AND APPROVAL OF SOPs:

4.4.1 The person responsible for writing new SOP and /or revised should have the working
knowledge of the SOP subject matter.
4.4.2 The SOP shall be reviewed by supervisory personnel who are responsible for
implementing and or working with the procedures
4.4.3 SOP shall then be approved by an individual who has the working knowledge of the SOP
subject matter and ensures that the procedure is in compliance with applicable
regulations. The approver usually is the head, Quality Assurance department or his
designee.
4.5 CONTROL AND DISTRIBUTION OF SOPs:
4.5.1 The author/Initiator of the new or revised SOP shall forward the original signed copy to the
respective department supervisor. The respective department supervisor shall review the
contents of the SOP and sign in Reviewed by column, if found acceptable forward to
Quality Assurance Department for final approval along with electronic copy.
4.5.2 QA head or his designee shall read the contents of SOP, if found acceptable shall approve
the SOP with sign / date in Approved by column. SOP shall be prepared in standard format
as shown in Exhibit-A.
4.5.3 The Manager or supervisor of each department shall receive the approved new or revised
SOP and explain the changes in the process and provide training to all subordinates on the
SOP within three weeks of receipt of SOP and complete the records for training as per SOP
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‘Staff Training Program’. The training records will be forwarded to the Quality Assurance
Department immediately after completion of training of the SOP. Once training is
completed, QA shall assign effective date to SOP.
4.5.4 Quality Assurance department personnel shall maintain the original SOPs by stamping
“ORIGINAL” in ‘RED’ color on every page at the left side top corner of SOP.
4.5.5 User copy shall be issued to Concerned/applicable or operational departments by Quality
Assurance personnel by photocopying the “ORIGINAL” stamped SOP. Quality Assurance
personnel shall stamp “ISSUED To ……” and ISSUED BY (QA) ……” in ‘GREEN’
color on the first page of SOP with sign and date on the right side top corner.
4.5.6 The department manager/supervisor receiving the SOP will sign for receipt of the SOP and
at the same time the receiving department individual shall return the copy of the obsolete
SOP to the Quality Assurance department, if applicable. The necessary information shall be
documented in "SOP DISTRIBUTION AND LOG" (Exhibit B), which shall state the
following:
a. SOP Title (subject)
b. SOP Number
c. SOP Revision Number
d. Sign /date SOP Issued and received by department personnel
e. Sign /date SOP returned and destroyed by for Obsolete copy
4.5.7 The retrieved obsolete SOP (s) shall be destroyed by Quality Assurance personnel.
4.5.8 Any SOP issued for non-operational use shall be stamped as ‘UNCONTROLLED COPY –
NOT FOR OPERATIONAL USE’ on every page in ‘BLUE’ color with signature and date
of QA personnel.
4.5.9 The manager or designee of each department shall maintain the current revision of SOP (s).
The SOP manual will be kept in the respective departments, which shall be accessible to all
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employees.
4.6 REVIEW OF SOPs:
4.6.1 All SOPs are to be reviewed once in every three years or as and when any changes are
desired and deemed necessary. Supervisory personnel in each department shall be
responsible for review of the SOP. Upon completion of review, the reviewer shall fill the
following information in the "Change Control Form" as per SOP Change Control
Procedure:
a) SOP title, number, revision number
b) Proposed changes and Justification(s) for changes
4.6.2 In case there are no changes observed at the end of three year review, SOP shall be
continued to be operative till further changes are initiated, implying no changes are
required. The SOP shall be stamped with ‘Reviewed due to Mandatory Reasons, No
Changes Required’ in revision history in black color duly signed and dated by Head QA or
designee.
4.6.3 The SOP review form (Exhibit – D) shall be used to indicate that there are ‘No changes
proposed’ in the column for proposed changes and ‘Reviewed due to mandatory reasons’
and forwarded by initiating department to QA for review & approval.
4.6.4 SOP revisions may be initiated for the following reasons:
a) Changes in the operating procedure(s) due to changes in existing regulation(s) or due
to changes recommended by the Food and Drug Administration, USP and / or ICH.
b) Changes in the operating procedure(s) due to improvement in existing procedure(s).
c) Accurately reflect the work as it occurs.
d) Editorial changes including any format changes.
Note: When a change in a SOP significantly alters a critical processing event, it shall
require the approval of Head Quality Management and or the Regulatory Affairs
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department before the change can be instituted.

4.7 PROCEDURE FOR REVISING SOPs:

4.7.1 Comments, corrections, revisions, in current SOPs shall be forwarded to the QA
department and evaluate the suggestion made by the reviewer. Fill the Change
Control Form. Review and approval will be followed as outlined in Sections 4.4 through
4.6.
4.7.2 Any SOP that has been revised requires updating the "SOP Revision History".
4.7.3 The "SOP Revision History Form" shall be able to track the date effective, revision
number and history of changes.
4.8 OBSOLETE SOPs:
4.8.1 Obsolete SOP’s are those, which are no longer being used due to any of the following
reasons:
a) Change or update in procedure or when equipment is no longer in use.
b) Incorporation of two or more SOP’s into one SOP.
c) Information addressed under other relevant SOP(s).
4.8.2 Only the Master SOP is retained by QA by stamping as “OBSOLETE” in center of every
page and all the issued user (superseded) copies shall be retrieved from the user
departments and shall be destroyed by QA.
5.0 EXHIBITS:
5.1 Standard Operating Procedure - Exhibit A
5.2 SOP Distribution and LOG – Exhibit B
5.3 Stamps – Exhibit C
5.4 SOP Review Form – Exhibit D
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6.0 REVISION HISTORY

REVISION NUMBER EFFECTIVE DATE REASON FOR CHANGES

00 06/15/2012 New SOP
1 Controlled Drug Substance
Department included and
typo errors corrected.
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 Title:

SOP # Revision: Effective Date: Page X o f Y

Written By/Date Reviewed By/Date Approved By/Date

EXHIBIT - A
 EXHIBIT - B

SOP DISTRIBUTION AND LOG

SOP Title :

SOP Number :
S.No Revision Department Issued by/date Received Returned Destroyed
Number by/date by/date by/date

AQA001-E01-00

EXHIBIT – D

SOP REVIEW FORM

Department :

SOP Title :

SOP Number : SOP Revision Number :

Proposed Changes: No Changes Required

Reason : Reviewed due to mandatory Reasons

Date of Review :

Dept. Head Head AQA

(Sign / Date): (Sign / Date):

AQA001-E02-00
Exhibit-C

STAMPS