LYF Research Canada. We provide FDA approved Raw Material indenting and drug testing services. Launching in Pakistan.-FDA approved sources-Testing and Raw Material indenting services

SCHEDULE B-II

of The Drugs (Licensing, Registering and Advertising) Rules, 1976 framed under the Drugs Act, 1976

(for details please refer to the Schedule)

Part-I

SECTION-1. GENERAL CONDITIONS

Remarks (against the sub-section below): Write the strong and weak points and observations. These remarks will appear in column 3 of cGMP Proforma. Grade each component as A, B, C or D

Responsibility of licensee for drug’s fitness for use

Remarks (if any): Write the strong and weak points and observations

Grading

(A, B, C or D)

SECTION 2. QUALITY ASSURANCE SYSTEM

REMARKS: Please write your remarks (strong and weak points and observations) against each sub-section below. It will appear in column 3 of cGMP Proforma. Grade each component as A, B, C or D based on your preset criteria

2(a.) drugs are designed and developed as per requirements of good manufacturing practices;

Remarks (if any): Write the strong and weak points and observations

Grading 2(a.)

2(b.) production and control operations are clearly specified in a written form and good manufacturing practices requirements are adopted and followed

Remarks (if any): Write the strong and weak points and observations

Grading 2(b.)

2(c.) managerial responsibilities are clearly specified in job descriptions;

Remarks (if any): Write the strong and weak points and observations

Grading 2(c.)

2(d.) arrangements are made for the manufacture, supply, and use of the correct starting and packaging materials;

Remarks (if any): Write the strong and weak points and observations

Grading 2(d.)

2(e.) all necessary controls on starting materials, intermediate products, and bulk products and other in process controls calibrations and validations are carried out;

Remarks (if any): Write the strong and weak points and observations

Grading 2(e.)

2(f.) the finished products are correctly processed and checked, according to the defined procedures;

Remarks (if any): Write the strong and weak points and observations

Grading 2(f.)

2(g.) finished drugs are not sold or supplied before the authorized person(s) has certified that each production batch has been produced and controlled in accordance with the requirements of the good manufacturing practices and the relevant rules made under the Act relevant to the production, control and release of drugs as well as of conditions of registration;

Remarks (if any): Write the strong and weak points and observations

Grading 2(g.)

2(h.) satisfactory arrangements exist to store in appropriate storage conditions;

Remarks (if any): Write the strong and weak points and observations

Grading 2(h.)

2(i.) Procedure for self inspection and or quality audit exists and documented;

Remarks (if any): Write the strong and weak points and observations

Grading 2(i.)

SECTION-3: QUALITY CONTROL

REMARKS: Please write your remarks (strong and weak points and observations) against each sub-section below. It will appear in column 3 of cGMP Proforma. Grade each component as A, B, C or D based on your preset criteria

3.1. Quality control department exists which is independent of other departments and under the authority of a person with the required qualifications and experience and with adequate facilities.

Record the reply/observation against each of the following questions (Q) under this subsection

3.1. (Q 1) Is QC Department housed in separate designated area;

3.1. (Q 2) Review of Technical staff list to verify that the QC staff is not engaged in other activities;

3.1. (Q 3) Review of DML to verify that the official occupying the position of Head of QC is the same as mentioned in DML. In case of difference, review the Change Letter.

3.2. Basic requirements:

3.2. (a.) During the period of validity of license, adequate facilities, trained personnel and approved procedures are available for sampling, inspecting, testing starting materials, packaging materials, intermediate, bulk, and finished products, and where appropriate for monitoring environmental conditions for good manufacturing practices purposes;

Record the reply/observation against each of the following questions (Q) under this subsection

3.2. (a.) (Q 1) Verify that the necessary equipment is available for sampling, inspecting, testing through cross relation from monographs;

Grading 3.2. (a.) (Q 1)

3.2. (a.) (Q 2) Reviews of JDs, training record and employee personal files;

Grading 3.2. (a.) (Q 2)

3.2. (a.) (Q 3) Review the temperature, humidity, pressure differentials and microbial monitoring record to verify that they are within / as per the specified limits.

Grading 3.2. (a.) (Q 3)

3.2. (b.) Samples of starting materials, packaging materials, intermediate products, bulk products and finished products are taken by methods, and personnel approved of by the quality control department.

Record the reply/observation against each of the following questions (Q) under this subsection

3.2. (b.) (Q 1): Review the SOPs to verify that they cover, at minimum, the following aspects:

Mark check to all that apply

Appropriate sample size;

Sampling approach to ensure the selection of representative sample;

Key considerations during sampling process;

Grading 3.2. (b.) (Q 1)

3.2. (b.) (Q 2) Review the BMR to verify that the sampling was carried out by the staff of QC department;

Grading 3.2. (b.) (Q 2)

3.2. (b.) (Q 3) Check physically the availability of sampling rods.

Grading 3.2. (b.) (Q 3)

3.2. (b.) (Q 4) Review the sample retention log book and physically observe the retained sample.

Grading 3.2. (b.) (Q 4)

3.2. (c.) Testing methods are validated;

(Detail in section 9)

3.2. (d.) Records are made that all the required sampling, inspecting and testing procedures have actually been carried out and that any deviation has been fully recorded and investigated;

Record the reply/observation against each of the following questions (Q) under this subsection

3.2. (b.) (Q1) Check record related to sampling, such as, sampling logs and BMR;

Grading 3.2. (b.) (Q1)

3.2. (b.) (Q2) Review Equipment utilization logs;

Grading 3.2. (b.) (Q2)

3.2. (b.) (Q3) Review of testing reports;

Grading 3.2. (b.) (Q3)

3.2. (b.) (Q4) Review of deviation record and logs;

Grading 3.2. (b.) (Q4)

3.2. (b.) (Q5) Review the Out of Specification (OOS) reports.

Grading 3.2. (b.) (Q5)

3.2. (c.) Testing methods are validated;

(Detail in section 9)

3.2. (d.) Records are made that all the required sampling, inspecting and testing procedures have actually been carried out and that any deviation has been fully recorded and investigated;

Record the reply/observation against each of the following questions (Q) under this subsection

3.2. (d.) (Q1) Check record related to sampling, such as, sampling logs and BMR

Grading 3.2. (d.) (Q1)

3.2. (d.) (Q2) Review Equipment utilization logs;

Grading 3.2. (d.) (Q2)

3.2. (d.) (Q3) Review of testing reports;

Grading 3.2. (d.) (Q3)

3.2. (d.) (Q4) Review of deviation record and logs

Grading 3.2. (d.) (Q4)

3.2. (d.) (Q5) Review the Out of Specification (OOS) reports

Grading 3.2. (d.) (Q5)

3.2. (e.) The finished products contain ingredients complying with the qualitative and quantitative composition of the product described in the marketing authorization.

Record the reply/observation against each of the following questions (Q) under this subsection

3.2. (e.) (Q1) Review of Finished Product Report.

Grading 3.2. (e.) (Q1)

3.2. (e.) (Q2) Review finish product test specifications.

Grading 3.2. (e.) (Q2)

3.2. (f.) Records are made of the results of inspecting and testing materials and intermediate, bulk and finished products against specifications and product assessment.

Record the reply/observation against each of the following questions (Q) under this subsection

3.2. (f.) (Q1) Review the following reports:

Once the review is complete, check the box that apply

RM report

PM report

Intermediate, Bulk/ Finished Goods Report

BMR

Grading 3.2. (f.) (Q1)

3.2. (f.) (Q2) Review of equipment utilization record and cross verification with the above reports.

Grading 3.2. (f.) (Q2)

3.2. (g.) No batch of product is released for sale prior to certification by the authorized person(s) that it is in accordance with the requirement of the rules.

Record the reply/observation against each of the following questions (Q) under this subsection

3.2. (g.) (Q1) Review of Finished Goods (FG) Report;

Grading 3.2. (g.) (Q1)

3.2. (g.) (Q2) Check BMR release date and Batch dispatch date and final test release date.

Grading 3.2. (g.) (Q2)

3.2. (h.) Sufficient samples of starting materials and products are retained to permit future examination of the product.

(Already covered in (b) above)

3.2. (I.) All quality control procedures are established, validated and implemented; the reference standards for substances are evaluated maintained, and stored; correct labeling of containers of materials and products is ensured; the stability of the active pharmaceutical ingredients and products is monitored. Complaints related to the quality of the product are investigated. All these operations shall be carried out in accordance with written procedures.

3.2. (i.) (Q1) Check the availability of Official Reference / Manufacturers Standards (USP, NF, BP, EP, etc.);

Grading 3.2. (i.) (Q1)

3.2. (i.) (Q2) Verify that the RS/ MS are stored as per requirements of Certificate of Analysis of RS/MS;

Grading 3.2. (i.) (Q2)

3.2. (i.) (Q3) Verify that the RS/MS are kept under the custody of a designated person in a secured area;

Grading 3.2. (i.) (Q3)

3.2. (i.) (Q4) Verify that RS/MS are used only for the purpose described in the appropriate testing method;

Grading 3.2. (i.) (Q4)

3.2. (i.) (Q5) Verify the validity;

Grading 3.2. (i.) (Q5)

3.2. (i.) (Q6) Check availability, validity and storage of secondary and working standards and whether they are established by the application of appropriate tests;

Grading 3.2. (i.) (Q6)

3.2. (i.) (Q7) Verify whether the secondary & working ref standard are periodically tested at regular intervals to ensure standardization;

Grading 3.2. (i.) (Q7)

3.2. (i.) (Q8) Verify whether the in-house reference standards (if any) are based on official reference standards, if available;

Grading 3.2. (i.) (Q8)

3.2. (i.) (Q9) Verify whether the labels indicate concentration, date of manufacture, expiry, date and storage conditions;

Grading 3.2. (i.) (Q9)

3.2. (i.) (Q10) Verify the stability reports;

Grading 3.2. (i.) (Q10)

3.2. (i.) (Q11) Trace back testing, utilization log of testing equipment and attendance of analyst;

(For further guidance on stability of API and Product, refer to section 3.3.7)

Grading 3.2. (i.) (Q11)

3.2. (i.) (Q12) For complaints, refer to section 3.6.

Grading 3.2. (i.) (Q12)

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