Procedure For Review And Approval Of Analytical Raw Data

PROCEDURE  

                   

          4.1. The reviewer shall ensure the following at the time of reviewal of the documents.

            4.1.1.  All the relevant details of the tested material.

             4.1.2.  Correct & Current Specification No.

            4.1.3.   All the tests are performed as per the required specifications.

4.1.4.    Correct use of working standard and its potency along with WS..No.

4.1.5.     Correct use of HPLC columns.

4.1.6.     All print- out chromatograms duly signed & dated by the Analyst should be attached.

4.1.7.     The raw data shall contain the Instrument No, used for the analysis.

4.1.8.    Correct Normality is used.

4.1.9    Correct units for measurements are mentioned.

         4.2.     The reviewar shall also ensure for the following,

         4.2.1.      Rounding off the results is done.

        4.2.2.     Correctness of the calculations.

       4.2.3.     Justifications for discarding the data ( if any )

                   4.2.4.  After going through the above mentioned requirements, the reviewers shall put his Signature    

             & date on the raw analytical data. 

Formats for sampling of Packaging material

ANNEXURE  - 1

REF. SOP NO.:	Revision No.     :  00	Page No.:  1 of 1
	Effective From :

PACKAGING MATERIAL REGISTER

                                                                                                                                                                                                                                     

Sr. No.

Date of Receipt

Name of the Material

Name of the mfgr. / Supplier

Batch No.

Mfg. Date

Expiry Date

GRN No./ Date

Quantity Received

No. of container/ packing

Sampling (Quantity/ Done by Date

Status for Approved Rejected material

Analytical Reference No. (A.R. No.)

Control Sample  Kept

Report filed

Analysis

Signature / Date

Remarks (if any)

ANNEXURE  - 2

REF. SOP NO.:	Revision No.     :  00	Page No.:  1 of 1
	Effective From :

SAMPLER’S REMARK OF PACKAGING MATERIAL

                                                                                                                         

1.	Name of Item :
2.	Name of manufacturer / Supplier:
3.	Item Code:			GRN No.:
4.	No. of packs / boxes received:			No. of packs / boxes sampled:
5.	Qty per box / pack:			Quantity Sampled:
6.	Total Quantity Received:			Date of Sampling:
Physical Condition of Consignment
7.	Nature of containers	Wooden/ polythene Bag / Gunny Bag / Paper Bag / Corrugated Others…….………………
8.	Physical condition of consignment	OK/ NOT OK  (Torn / Seal open / Damage)
9.	Source of Material	Approved vendor / other
10.	Analytical Report (COA)	Received / Not Received
11.	Cleaning Of Surrounding area of consignment	Ok  / Not Ok.
12.	Proper Consignment label Affixed by Party	Yes / No.
13.	Proper Quarantine Label Affixed by Warehouse	Yes / No.
14.	After sampling resealing of boxes done	Yes / No.
15.	Remarks:
Sampled by: (Sign / Date)			Checked by: (Sign / Date)

ANNEXURE  - 3

FORMAT FOR CLEANING RECORD OF LAMINAR AIR FLOW

REF. SOP NO.:	Revision No.     :  00	Page No.:  1 of 1
	Effective From :

Sr. No.	Date of Cleaning	Cleaning Done By	Checked By	Remarks

105 D MILITARY STANDARD ACCEPTABLE QUALITY LEVEL (AQL) CHART

(NORMAL INSPECTION)

Sample size code letter.	Batch Size	No. of samples for visual inspection	Critical [AQL level 0.65]		Major [AQL level 1.5]		Minor [AQL level 2.5]
			ACC	REJ	ACC	REJ	ACC	REJ
A	2 to 8	2	0	1	0	1	0	1
B	9 to 15	3	0	1	0	1	0	1
C	16 to 25	5	0	1	0	1	0	1
D	26 to 50	8	0	1	0	1	0	1
E	51 to 90	13	0	1	0	1	1	2
F	91 to 150	20	0	1	0	1	1	2
G	151 to 280	32	0	1	1	2	2	3
H	281 to 500	50	1	2	2	3	3	4
J	501 to 1200	80	1	2	3	4	5	6
K	1201 to 3200	125	2	3	5	6	7	8
L	3201 to 10000	200	3	4	7	8	10	11
M	10001 to 35000	315	5	6	10	11	14	15
N	35001 to 150000	500	7	8	14	15	21	22
P	150001 to 500000	800	10	11	21	22	21	22
Q	500001and above	1250	14	15	21	22	21	22

Note: ACC: Acceptance

           REJ:   Rejection