1.0
OBJECTIVE:
To lay down the procedure for document management system
and destruction of all documents.
2.0
SCOPE:
This SOP is
applicable to the entire documents management and destruction (except account
and Excise department) available in -------------------------
3.0
RESPONSIBILITY:
The
responsibility of document control lies with all concerning Department Heads.
4.0
ACCOUNTABILITY:
The Accountability of compliance of the sop is of all
Department Heads.
The
Accountability of implementation and compliance of the SOP is of Quality
Assurance Head.
5.0
PROCEDURE:
5.1
DOCUMENT MANAGEMENT SYSTEM:
5.1.1
There is a
master standard operating procedure (SOP) for the preparation of other SOPs,
STP, STS and related documents of all departments.
5.1.2
User
departments are responsible for preparation and revision of the documents. User
department Head shall approve all the related documents and QA Head shall
provide final authorization of all the documents. The distribution, retrieval
and destruction of the documents shall be done by QA department after
authorization by QA Head. Necessary records shall be maintained for issuance
and destruction.
5.1.3
All the Master documents shall be stored with QA
department.
5.1.4
Controlled copy of the documents shall be distributed
to User Department by QA Department.
5.2
The other
documents prepared at the site are:
5.2.1
Site Master
File
5.2.2
Quality
Manual
5.2.3
Validation
Master File
5.2.4
Validation
Protocols and reports (air handling unit validation, instrument qualification,
equipment qualification, computer validation, water system validation, process
validation, cleaning validation, etc).
5.2.5
Analytical
Method Validation
5.2.6
Master
Formula Records (MFR)
5.2.7
Batch
Manufacturing Record (BMR) and Batch packaging record (BPR)
5.2.8
Standard
operating procedures
5.2.9
Internal
Audit Reports
5.2.10 Standard Products Specifications
5.2.11 Standard Testing procedures
5.2.12 Annual Product Quality Review
5.2.13 Job Responsibilities
5.2.14 Approved Vendor List
5.2.15 In Process Control Specifications
5.3
Document control is the responsibility of QA
Department. All the documents like BMR/ BPR, Standard Operating Procedures,
Specifications, STP, Validation protocols/Reports etc. are controlled by QA
Department.
5.4
5.6
DISTRIBUTION AND
CONTROL OF DOCUMENTS:
Distribution and
control of documents is the responsibility of QA Department.
5.6.1
QA Officer / Executive shall receive the request for required documents
and formats in Document Issuance requisition Format No.: F/QA-013-01
duly signed with reason for the requirement.
5.6.2
The Document and formats Issuance Requisition shall be approved by
concerned Department Head or his designee and authorized by QA Head or his
designee.
5.6.3
After the
authorization of requisition by QA Head, quality assurance officer/executive
shall allocate the unique requisition number as per following procedure.
The Document Issuance requisition shall be numbered as
- @@/DR/XXYYY
Where @@ indicates the name of the Department raising
the requisition.
DR - Document Requisition.
XX - Year, (18 for 2018)
YYY - Serial Number (001)
Codes for individual department shall be as follows –
|
Sr. no. |
Department |
Code No. |
|
0.1 |
Quality Assurance |
QA |
|
2.0 |
Quality Control |
QC |
|
3.0 |
Engineering |
EG |
|
4.0 |
Personnel & Administration |
PA |
|
5.0 |
Production |
PD |
|
6.0 |
Ware house (RM/PM) |
WH |
|
7.0 |
Finished Goods |
FG |
DR
– Document Requisition.
X
– The last digit represent for the Year 2015
YYY
– Serial number of requisition
5.6.4
Controlled
Documents
Documents which are
used by various departments as reference documents/ guidance/ record purpose
and which are version controlled shall be issued as controlled copies.
5.6.5
Uncontrolled
Documents
When a document which is
issued as controlled documents within the premises is required to be issued as
hard copies to outside agency, then shall be issued as uncontrolled copy.
However when the same document sent to the concerned party/ authority etc
through mail, then these shall be issued as scanned copies of master copies
(i.e. without any uncontrolled stamp)
5.6.6
Site Master File, Quality Manual, VMP etc are though
version controlled but meant for
distribution to external agencies, shall be issued as photocopies or as
scanned mail copy.
5.6.7
Documents like index of Standard Operating Procedures,
Approved vendor list, documents received from other parties (e.g. approved
vendor list, standard test procedures, raw materials and packaging material
specifications, technology transfer documents etc) which are required to be
distributed, shall be distributed by QA Department.
5.6.8
The
documents which shall be used by the individual department shall be photocopied
by QA department on written request and stamped with the following stamp in blue
ink before issue. The records for issuing the documents shall be
maintained.
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5.6.9
When the
formats are to be issued as preprinted registers or log books, then these individual
pages has to be numbered and these are submitted to QA Department for issuance.
The log books shall be issued by putting above
stamp on first page whereas
the back side of last page and front page back side
shall be stamped with below stamp with remark
so as to indicate the number of pages from to
in the log book. The records for issuing the
formats or log books shall be maintained in “Document Issue,
Retrieval Log” F/QA-013-02.
5.6.10 Similarly BMR/ BPR,
on requisition by Production, shall be issued by QA department with above stamp
in red ink on all pages and duly signed and dated by QA Officer.
5.6.11
|
5.7
RETRIEVAL OF DOCUMENTS:
5.7.1
If
any document is revised or deleted, then all the copies of the previously
distributed documents shall be withdrawn by QA department.
5.7.2
The Master Copy of the previously distributed documents shall be stamped with “OBSOLETE
COPY” stamp with sign and dated by QA
Officer and kept in QA department. The previously distributed
documents shall be stored &
destruction after retrieving as per SOP No.: SOP-QA-27
|
5.7.3
If
any Format is revised or deleted, then all the copies of the previously
distributed Format or Log Books shall be returned to QA department. The empty pages
of the log book shall be striked out. Records of the same is maintained in, “Document Issue,
Retrieval Log” F/QA-013-02 and shall
be stored with QA department for any reference in future.
5.7.4
The
log books running and/ or completed during the year, shall be maintained with
respective user department during the year. However at end of the calendar
year, all the formats or log books which are completed, like Area cleaning, Temp./
%RH monitoring, Balance records verification , riser filter cleaning ,
fly-o-cide cleaning etc. shall be submitted to QA
department at
the end of its time period (i.e end of year).
5.8
Master copy
of all the Documents shall be kept with QA Department in proper manner such that
there is no risk of loosing them or getting damaged. Documents stored in
electronic form (in the form of soft copy) must be subjected to the same level
of control as those in hard copy form and must be held for the periods defined
for hard data using a method which protects the data from loss, alteration or
completion and enables retrieval and releasing of the record during the defined
storage time period.
5.9
All
the documents shall be stored in QA Documentation room with proper status label.
The respective document shall be destroyed by shredding, after the defined
storage period as per SOP No.: SOP-QA-027.
5.10
All the live
documents shall be reviewed in every two years or earlier when required for any
updation in the documents unless otherwise specified on the documents. Periodic
revision of the documents requires no change control whereas any updation in
the documents requires change control.
5.11
Document Rectification
5.11.1 Overwriting in the
documents shall be avoided.
5.11.2 If there is any mistake or
typographical error observed in the already implemented document (such as
SOP’s, STP’s etc.), Document
Rectification form to that particular document
shall be prepared as per Annexure-I and the document shall not go under
revision immediately however the correction shall be taken into the
consideration during subsequent revision of the document.
5.11.3 The approved document
rectification form shall be attached along with
the master document and control copies issued.
5.11.4 For executed documents (such as issued BMR, Issued formats etc.), if
any error is cited in the document same shall be corrected by individual department
& counter sign by QA. Error shall be immediately corrected in the master
document and sign by QA; same shall be corrected in the master document during
next revision.
6.0
LIST OF ANNEXURE AND FORMATS:
|
Sr. No. |
Title of
Format |
Format No. |
|
|
Requisition for Document
Issuance. |
F/QA-013-01 |
|
|
Document Issue, Retrieval
Log. |
F/QA-013-02 |
|
|
External document
receiving, issuance and retrieval record. |
F/QA-013-03 |
|
|
Index of SOP. |
F/QA-013-04 |
|
|
Document Rectification Form |
F/QA-013-05 |
|
|
Issuance of Master and
other documents for reference purpose |
F/QA-013-06 |
|
|
Check List of Log Book
Retrieval. |
F/QA-013-07 |
7.0
REFERENCES:
7.1
SOP-QA-001
7.2
SOP-QA-014
7.3
F/QA-001-01
7.4
SOP-QA-027.
7.5
F/QA-038-01
8.0
REVISION HISTORY:
|
Sr. No. |
Date |
Reason for Revision |
Revision No |
|
1.
|
31/10/2018 |
New SOP |
R0 |
|
2.
|
31/10/2020 |
Schedule Revision |
R1 |
9.0
ABBREVIATIONS:
|
Sr. No |
Abbreviations |
Details |
|
01 |
QA |
Quality Assurance |
|
02 |
SOP |
Standard operating
procedure |
END
OF DOCUMENT
From, Date:______________________________
Department:___________________
Section:______________________ Requisition No.:_____________________
To,
Quality Assurance Department
Please issue the following documents:
|
Sr. No. |
Name
Of Document |
Document No. |
Reason for
Issuance |
No. of
Copies |
Returnable
/ Non Returnable |
Tentative
Date of Returning |
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Requisition
By |
Department
HOD Checked By |
QA
Designee / HOD Approved By |
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Date |
Req. No. |
Name Of Document |
Document No. |
No. Of Copies |
Copies Distributed to |
Issued by/on |
Received by/on |
Retrieved by /on |
Received back by/on |
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Pharmaceutical guideline only