sop for approval of Contract Parties

1.0 OBJECTIVE :
1.1 To lay down a procedure for approval of contract parties.

2.0. SCOPE :
2.1 This procedure is applicable to approve contract parties providing services
2.1.1 Contract testing,
2.1.2 Annual maintenance service,
2.1.3 Calibration/validation service,
2.1.4 Laundry service,
2.1.5 Pest-control service,
2.1.6 Fire-extinguisher service,
2.1.7 Medical check-up service, etc.

3.0. RESPONSIBILITY :
3.1 Concern department manager/head shall be responsible:
3.1.1 To confirm the reliability of service provided by contract parties through visit/audit/document verification so as to ensure GMP/GLP compliance.
3.1.2 To have written approved contract between Company and contract parties.
3.1.3 To inform QA Head on approval/rejection of contract parties.
3.1.4 To forward copy of approved contract to QA Head.

3.2 QA officer shall be responsible:
3.2.1 To prepare list of approved contract parties and get it approved by QA Head.
3.2.2 To maintain the file of copy of approved contracts.

4.0. ACCOUNTABILITY : Concern department Head.

5.0. PROCEDURE :

5.1. APPROVAL OF CONTRACT TESTING LABORATORIES
5.1.1 During finalization of specification of RM, PM or FP, QC manager/head

shall review the available requirement in QC facility and prepare the list testing

parameters required to be analyzed at contract testing laboratories (CTL) due

to non-available facility in QC, if any.
5.1.2 QC manager/head shall identify the contract testing laboratories (ONLY GOVERNMENT APPROVED) wherein such parameters can be analyzed.
5.1.3 QC manager/head shall audit the identified CTL as per ‘Audit Check-list for

Contract Testing Laboratory’ (Annex-I) but not necessary limited to the checklist.
5.1.4 QC manager/head shall also verify the compliance level of finding of last audit

(in case of periodic audit i.e. once in two years).
5.1.5 As per the findings/observations made into checklist, QC manager/head shall

prepare audit report in Annex-I at the CTL site itself.
5.1.6 In case of any non-conformities observed during audit, QC manager/head shall

get it rectified in his/her presence only along with finalized corrective and preventive actions.
5.1.7 If CTL is able to comply the observed non-conformities in presence of

QC manager/head, later one shall discuss ‘Contract with Contract

Testing Laboratory’ (Annex-II) with CTL head.
5.1.8 QC manager/head shall explain the requirements of terms and conditions

mentioned in Annex-II to CTL head.
5.1.9 If CTL head agrees with terms and conditions mentioned in Annex-II,

QC manager/head shall approve CTL and sign/date in Annex-I and Annex-II.
5.1.10 QC manager/head shall periodically audit approved CTL once in

two years and follow the procedure mentioned in point no. 5.1.3 to 5.1.9.
5.1.11 QC manager/head shall inform QA head for approval/rejection of

CTL along with copy of approved Annex-II.
5.1.12 QA head shall forward copy of approved Annex-II to QA officer/executive

who shall in turn amend the ‘List of Contract Parties’ (Annex-III) and get it

approved by QA Head. QA officer/executive shall then file this approved

Annex-II as well as Annex-III.

5.2. APPROVAL OF CONTRACT PARTIES OTHER THAN CTL
5.2.1. If in case, any facility not available to execute the SOP (for example,

Annual maintenance of equipment/instruments, calibration/validation

of equipment/instruments, laundry service, pest-control, fire-extinguisher,

medical check-up, etc.), concern department manager/head shall identify

the contract service providers.
5.2.2. Concern department manager/head shall discuss ‘Contract with

Contract Service Providers’ (Annex-IV) with head/owner of the party.
5.2.3. Concern department manager/head shall explain the requirements

of terms and conditions mentioned in Annex-IV to head/owner of the party.
5.2.4. If head/owner of the party agrees with terms and conditions mentioned

in Annex-IV, concern department manager/head shall approve that party

and sign/date in Annex-IV.
5.2.5. Concern department manager/head shall inform QA head for

approval/rejection of party along with copy of approved Annex-IV.
5.2.6. QA head shall forward copy of approved Annex-IV to QA officer/executive

who shall in turn amend the ‘List of Contract Parties’ (Annex-III) and get it

approved by QA Head. QA officer/executive shall then file this approved Annex-IV.

6.0 ABBREVIATION :

Sr. No.	Abbreviation used	Full form of abbreviation used
1.	GMP	Good Manufacturing Practices
2.	GLP	Good Laboratory Practices
3.	QA	Quality Assurance department
4.	RM	Raw Material
5.	PM	Packing Material
6.	FP	Finished Product
7.	QC	Quality Control department
8.	CTL	Contract Testing Laboratory
9.	SOP	Standard Operating Procedure

7.0 ATTACHMENTS (ANNEXES) :
Annex-I : Audit Check-list for Contract Testing Laboratory
Annex-II : Contract with Contract Testing Laboratory
Annex-III : List of Contract Parties
Annex-IV : Contract with Contract Service Providers

8.0. REFERENCE :

Good manufacturing practices and inspection, WHO

process validation protocol for methylcobalamin niacinamide and pyridoxine injection

validation protocol of sterility test

sop for Analytical Method Transfer

Protocol for hold time study of sterile garments

sop for process validation

sop for swab sampling for validation of clean surfaces

cleaning validation maco and noel calculation formula

sop for performance qualification for analyst

Sop for Validation report for disinfectant efficacy

Sop for Method validation report for bacterial endotoxin test